<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03253471</url>
  </required_header>
  <id_info>
    <org_study_id>AL-611-1101</org_study_id>
    <nct_id>NCT03253471</nct_id>
  </id_info>
  <brief_title>A First in Human Study of AL-611 in Healthy Volunteers and Patients With Hepatitis C Virus Infection</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, First-in-human, 3 Part Study of Orally Administered AL-611 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part 3) of Single Ascending Doses in Healthy Volunteers (Parts 1-2), and Multiple Ascending Doses in Subjects With Chronic Hepatitis C Virus Infection (Part 3)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alios Biopharma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alios Biopharma Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,&#xD;
      tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally&#xD;
      administered AL-611 in healthy volunteers (HV; Parts 1-2) and subjects with CHC (Part 3).&#xD;
&#xD;
      Part 1: HV will receive 1 of 5 single ascending doses (SAD) of AL-611 Part 2: Eight HV from&#xD;
      Cohort 3 in Part 1 are planned to receive a second single dose of AL-611 or placebo (as per&#xD;
      their randomized assignment in Part 1) in a fed state after a washout period Part 3: Subjects&#xD;
      with CHC infection will receive 1 of 3 planned multiple ascending doses (MAD)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Strategic decision to discontinue further development of investigational compounds for the&#xD;
    treatment of hepatitis C.&#xD;
  </why_stopped>
  <start_date type="Actual">July 7, 2017</start_date>
  <completion_date type="Actual">September 18, 2017</completion_date>
  <primary_completion_date type="Actual">September 18, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of Treatment emergent Adverse events</measure>
    <time_frame>Up to 21 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical examination findings</measure>
    <time_frame>Up to 21 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of vital sign abnormalities</measure>
    <time_frame>Up to 21 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of 12 lead electrocardiagram abnormalities</measure>
    <time_frame>Up to 21 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of clinical laboratory abnormalities</measure>
    <time_frame>Up to 21 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C0_h of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</measure>
    <time_frame>Day 1 to Day 21</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentrations in urine of AL-611 and ALS 022358 (and other metabolites if applicable) after a single oral dose</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>Concentrations in urine of AL-611 and ALS 022358 (and other metabolites if applicable) after a single oral dose in HV in fasted conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HCV RNA viral load in subjects with CHC</measure>
    <time_frame>Screening to Day 21</time_frame>
    <description>HCV RNA viral load (over time, maximum decrease from baseline, and change from baseline over time) in subjects with CHC, defined by GT and host characteristic (eg, presence/absence of compensated cirrhosis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sequence analysis of HCV</measure>
    <time_frame>Day 1 to Day 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C24h of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tlast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F of AL-611 following single dose administration</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>PK parameter of AL-611 following single dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-inf of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</measure>
    <time_frame>Day 1 to Day 8</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</measure>
    <time_frame>Day 1 to Day 21</time_frame>
    <description>PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</measure>
    <time_frame>Day 1 to Day 21</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</measure>
    <time_frame>Day 1 to Day 21</time_frame>
    <description>PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</measure>
    <time_frame>Day 1 to Day 21</time_frame>
    <description>PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</measure>
    <time_frame>Day 1 to Day 21</time_frame>
    <description>PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0_tau of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</measure>
    <time_frame>Day 1 to Day 21</time_frame>
    <description>PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>AL-611</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to Match AL-611</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AL-611</intervention_name>
    <description>AL-611 tablets</description>
    <arm_group_label>AL-611</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to Match AL-611</description>
    <arm_group_label>Placebo to Match AL-611</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided written consent.&#xD;
&#xD;
          -  In the investigator's opinion, the subject is able to understand and comply with&#xD;
             protocol requirements, instructions, and protocol stated restrictions and is likely to&#xD;
             complete the study as planned.&#xD;
&#xD;
          -  Except in compensated cirrhosis (cirrhosis cohorts only) and diagnosis of HCV (Part 3&#xD;
             only), subject is in good health as deemed by the investigator, based on the findings&#xD;
             of a medical evaluation including medical history, physical examination, laboratory&#xD;
             tests, and ECG.&#xD;
&#xD;
          -  Male or female, 18-60 years of age for HV and 18-70 years of age for subjects with&#xD;
             CHC.&#xD;
&#xD;
          -  Body mass index (BMI) 18-30 kg/m2, inclusive, for HV and 18-35 kg/m^2, inclusive, for&#xD;
             subjects with CHC. The minimum weight is 50 kg in both populations.&#xD;
&#xD;
          -  A female subject is eligible to participate in this study if she is of&#xD;
             non-childbearing potential (defined as females with a documented tubal ligation,&#xD;
             bilateral oophorectomy, or hysterectomy) or postmenopausal (defined as 12 months of&#xD;
             spontaneous amenorrhea and follicle stimulating hormone (FSH) level within the&#xD;
             laboratory's reference range for postmenopausal females).&#xD;
&#xD;
          -  If male, subject is surgically sterile or practicing specific forms of birth control&#xD;
             until 6 months after the end of the study. Male subjects must agree to refrain from&#xD;
             sperm donation from start of dosing through 6 months after the completion of study&#xD;
             drug administration.&#xD;
&#xD;
          -  Subject agrees to refrain from blood donation from screening until 56 days after the&#xD;
             last study visit.&#xD;
&#xD;
          -  For HV, estimated glomerular filtration rate (eGFR) in the normal range as determined&#xD;
             by modification of diet in renal disease (MDRD) formula. For CHC (Part 3)&#xD;
             eGFR&gt;60ml/min/1.73m^2 as determined by MDRD (alternative calculations (eg,&#xD;
             Cockroft-Gault) may be permissible, if approved by the Sponsor).&#xD;
&#xD;
        Additional inclusion criteria for subjects with CHC infection (Part 3):&#xD;
&#xD;
          -  Subjects must have GT1 or GT3 CHC (or GT1-6 for Part 3 optional cohorts) infection&#xD;
             identified at screening.&#xD;
&#xD;
          -  Documentation of HCV infection for greater than 6 months before randomization as&#xD;
             defined by either documented HCV serology demonstrating the presence of anti-HCV&#xD;
             antibodies at least 6 months before randomization or documented presence of HCV RNA at&#xD;
             least 6 months before randomization.&#xD;
&#xD;
          -  Screening HCV RNA viral load ≥50,000 IU/mL (except for subjects with compensated&#xD;
             cirrhosis, who may have HCV RNA viral load ≥10^4 IU/mL) using Ampliprep COBAS® Taqman®&#xD;
             HCV Test 2.0&#xD;
&#xD;
          -  Cirrhotic subjects in Part 3 must have compensated cirrhosis AND meet the Child-Pugh&#xD;
             Class A definition AND have a screening Fibroscan with a liver stiffness score&gt;12.5&#xD;
             kPa.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History or other clinical evidence of significant or unstable cardiac disease (eg,&#xD;
             angina, congestive heart failure, myocardial infarction, diastolic dysfunction,&#xD;
             significant arrhythmia (eg, long QT syndrome, torsades de pointes), coronary heart&#xD;
             disease), moderate to severe valvular disease or poorly controlled hypertension at&#xD;
             screening.&#xD;
&#xD;
          2. Family history of prolonged QT syndrome (eg, torsade de pointes) or sudden cardiac&#xD;
             death.&#xD;
&#xD;
          3. Clinically significant abnormal screening ECG findings (eg, PR &gt;220 msec, QRS interval&#xD;
             &gt;120 msec or corrected QT interval (QTcF) &gt;450 msec for male subjects and &gt;470 msec&#xD;
             for female subjects).&#xD;
&#xD;
          4. Participation in either an investigational drug trial or an investigational vaccine&#xD;
             trial within 30 days or 5 half lives (whichever is longer) prior to starting study&#xD;
             medication.&#xD;
&#xD;
          5. Clinically significant blood loss or elective blood donation of significant volume&#xD;
             (ie, &gt;500 mL) within 60 days prior to screening; &gt;1 unit of plasma within 7 days prior&#xD;
             to screening.&#xD;
&#xD;
          6. Unwilling to abstain from alcohol for 48 hours prior to the start of dosing through&#xD;
             the study completion visit.&#xD;
&#xD;
          7. History of regular alcohol intake &gt;14 units per week of alcohol for females and &gt;21&#xD;
             units per week for males (one unit is defined as 10 g alcohol) within 3 months of&#xD;
             randomization&#xD;
&#xD;
          8. The subject has a positive alcohol test at screening or on Day -2.&#xD;
&#xD;
          9. Hypersensitivity to the active substance or to any of the excipients of AL-611&#xD;
&#xD;
         10. Abnormal (using local normal range) heart rate, respiratory rate, temperature or blood&#xD;
             pressure (BP) values (evaluated in a semi-recumbent or recumbent position after 5&#xD;
             minutes of rest). One repeat measurement after an additional ~5 minutes of rest is&#xD;
             permitted. In addition, a repeat measurement performed on a separate day is also&#xD;
             permitted.&#xD;
&#xD;
         11. Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hepatic,&#xD;
             hematologic, neurologic, oncologic (except adequately treated basal cell carcinoma and&#xD;
             cervical intraepithelial neoplasia [CIN] I or II), autoimmune, or any other medical&#xD;
             illness or psychiatric disorder, as determined by the Investigator. CHC with/without&#xD;
             compensated cirrhosis acceptable for cohorts enrolling CHC subjects with/without&#xD;
             compensated cirrhosis, respectively, but non-HCV related hepatic disease is&#xD;
             exclusionary.&#xD;
&#xD;
         12. Positive test for hepatitis A virus (HAV) IgM, hepatitis B surface antigen (HBsAg), or&#xD;
             human immunodeficiency virus (HIV) antibody. For HV HCV is exclusionary.&#xD;
&#xD;
         13. Evidence of active infection (topical fungal infections which are considered not&#xD;
             clinically significant are permitted). CHC is inclusionary for Part 3 only.&#xD;
&#xD;
         14. History of regular use of tobacco (ie, ≥10 cigarettes per day or equivalent for&#xD;
             alternative nicotine products (eg, e cigarettes)) within 3 months of randomization.&#xD;
&#xD;
         15. The subject has a positive drug screen during screening or on Day -2. For CHC,&#xD;
             prescribed medications with a stable dose for at least 21 days may be considered by&#xD;
             the Investigator and Sponsor Medical Monitor; cannabis is permitted.&#xD;
&#xD;
         16. From 14 days (or 5 half-lives, whichever is longer) prior to admission to the Phase 1&#xD;
             Unit until randomization, use of any medications, including prescription, over the&#xD;
             counter, and herbal medications, is exclusionary. The only exceptions are&#xD;
             acetaminophen, ibuprofen, hormone replacement therapy, and thyroid hormone replacement&#xD;
             therapy.&#xD;
&#xD;
         17. Abnormal screening laboratory results that are considered clinically significant by&#xD;
             the investigator or as specified in the protocol.&#xD;
&#xD;
             Additional exclusion criteria for subjects with CHC (Part 3):&#xD;
&#xD;
         18. History of clinical hepatic decompensation, eg, variceal bleeding, spontaneous&#xD;
             bacterial peritonitis, ascites, hepatic encephalopathy or active jaundice (within the&#xD;
             last year).&#xD;
&#xD;
         19. Except subjects with compensated cirrhosis, a liver biopsy within 2 years that&#xD;
             demonstrates cirrhosis (Knodell score &gt;3, Metavir score &gt;3, Ishak score &gt;4) or a&#xD;
             screening Fibroscan liver stiffness score &gt;12.5 kPa.&#xD;
&#xD;
         20. Prior treatment for CHC, defined as prior exposure to any approved or investigational&#xD;
             drugs intended to treat HCV infection. In subjects with compensated cirrhosis, prior&#xD;
             relapse after a complete course of, or premature discontinuation from,&#xD;
             interferon-based treatment regimens (±ribavirin) is acceptable, but prior exposure to&#xD;
             any direct-acting antivirals (DAAs) is exclusionary.&#xD;
&#xD;
         21. Evidence on screening liver ultrasound of hepatic mass or lesion concerning for&#xD;
             malignancy (subjects with cirrhosis only).&#xD;
&#xD;
         22. For CHC subjects without cirrhosis, alpha fetoprotein (AFP) concentrations ≤ upper&#xD;
             limit of normal (ULN). If AFP is &gt;ULN, absence of a hepatic mass or lesion must be&#xD;
             demonstrated by ultrasound within the screening period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mina Pastagia</last_name>
    <role>Study Director</role>
    <affiliation>Alios Biopharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SGS Life Sciences</name>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>October 23, 2017</last_update_submitted>
  <last_update_submitted_qc>October 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253471
org study id: AL-611-1101
nct id: NCT03253471
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,
      tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally
      administered AL-611 in healthy volunteers (HV; Parts 1-2) and subjects with CHC (Part 3).

      Part 1: HV will receive 1 of 5 single ascending doses (SAD) of AL-611 Part 2: Eight HV from
      Cohort 3 in Part 1 are planned to receive a second single dose of AL-611 or placebo (as per
      their randomized assignment in Part 1) in a fed state after a washout period Part 3: Subjects
      with CHC infection will receive 1 of 3 planned multiple ascending doses (MAD)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence and severity of Treatment emergent Adverse events
time frame: Up to 21 days
measure: Physical examination findings
time frame: Up to 21 days
measure: Incidence and severity of vital sign abnormalities
time frame: Up to 21 days
measure: Incidence and severity of 12 lead electrocardiagram abnormalities
time frame: Up to 21 days
measure: Incidence and severity of clinical laboratory abnormalities
time frame: Up to 21 days
measure: Cmax of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
time frame: Day 1 to Day 8
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
measure: C0_h of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
time frame: Day 1 to Day 21
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
measure: Concentrations in urine of AL-611 and ALS 022358 (and other metabolites if applicable) after a single oral dose
time frame: Day 1 to Day 8
description: Concentrations in urine of AL-611 and ALS 022358 (and other metabolites if applicable) after a single oral dose in HV in fasted conditions
measure: HCV RNA viral load in subjects with CHC
time frame: Screening to Day 21
description: HCV RNA viral load (over time, maximum decrease from baseline, and change from baseline over time) in subjects with CHC, defined by GT and host characteristic (eg, presence/absence of compensated cirrhosis)
measure: Sequence analysis of HCV
time frame: Day 1 to Day 21
measure: tmax of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
time frame: Day 1 to Day 8
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
measure: C24h of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
time frame: Day 1 to Day 8
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
measure: Clast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
time frame: Day 1 to Day 8
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
measure: tlast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
time frame: Day 1 to Day 8
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
measure: t1/2 of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
time frame: Day 1 to Day 8
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
measure: CL/F of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
time frame: Day 1 to Day 8
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
measure: Vz/F of AL-611 following single dose administration
time frame: Day 1 to Day 8
description: PK parameter of AL-611 following single dose administration
measure: AUC0-inf of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
time frame: Day 1 to Day 8
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
measure: AUClast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
time frame: Day 1 to Day 8
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
measure: Cmax of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
time frame: Day 1 to Day 21
description: PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
measure: tmax of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
time frame: Day 1 to Day 21
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
measure: Cmin of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
time frame: Day 1 to Day 21
description: PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
measure: t1/2 of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
time frame: Day 1 to Day 21
description: PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
measure: AUClast of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
time frame: Day 1 to Day 21
description: PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
measure: AUC0_tau of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
time frame: Day 1 to Day 21
description: PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
arm group label: AL-611
arm group type: Experimental
arm group label: Placebo to Match AL-611
arm group type: Placebo Comparator
intervention type: Drug
intervention name: AL-611
description: AL-611 tablets
arm group label: AL-611
intervention type: Drug
intervention name: Placebo
description: Placebo to Match AL-611
arm group label: Placebo to Match AL-611
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mina Pastagia
role: Study Director
affiliation: Alios Biopharma
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Virus Diseases
mesh term: Hepatitis
sharing ipd: Undecided