xml: <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/NCT05966688</url>
    </required_header>
    <id_info>
      <org_study_id>SPR720-102</org_study_id>
      <nct_id>NCT05966688</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants</brief_title>
    <official_title>A Phase 1 Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Spero Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Spero Therapeutics</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of this study is to evaluate the pharmacokinetics (PK) of SPR720,&#xD;
        azithromycin, and ethambutol, administered separately and co-administered, in healthy adult&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>It is anticipated that participants will enroll one after another in each arm of this study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum Observed Plasma Concentration (Cmax) of Study Drug</measure>
      <time_frame>Pre-dose and at multiple time points post-dose up to Day 8</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to Attain Maximum Plasma Concentration (tmax) for Study Drug</measure>
      <time_frame>Pre-dose and at multiple time points post-dose up to Day 8</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Concentration-time Curve From Time Zero to Dosing Interval (AUC0-τ) for Study Drug</measure>
      <time_frame>Pre-dose and at multiple time points post-dose up to Day 8</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
      <time_frame>From the first dose of study drug through follow-up Day 13</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>SPR720 1000 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Azithromycin 500 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy participants will receive azithromycin 500 mg, orally, QD for 7 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ethambutol 800 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy participants will receive ethambutol 800 mg, orally, QD for 7 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SPR720</intervention_name>
      <description>Multiple oral doses of SPR720 capsules.</description>
      <arm_group_label>SPR720 1000 mg</arm_group_label>
      <arm_group_label>SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Azithromycin</intervention_name>
      <description>Multiple oral doses of azithromycin.</description>
      <arm_group_label>Azithromycin 500 mg</arm_group_label>
      <arm_group_label>SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ethambutol</intervention_name>
      <description>Multiple oral doses of ethambutol.</description>
      <arm_group_label>Ethambutol 800 mg</arm_group_label>
      <arm_group_label>SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body mass index (BMI) between ≥18.0 and ≤32.0 kilograms per meter square (kg/m^2) and&#xD;
               weight between 50.0 and 100.0 kilograms (kg) (inclusive) at the Screening visit.&#xD;
  &#xD;
            -  Medically healthy without clinically significant medical history, abnormalities in&#xD;
               physical examination, laboratory tests, vital signs, or electrocardiogram (ECG) at the&#xD;
               Screening visit.&#xD;
  &#xD;
            -  Has suitable venous access for repeated blood sampling.&#xD;
  &#xD;
            -  Has ability and willingness to abstain from alcohol, caffeine, xanthine-containing&#xD;
               beverages or food (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.)&#xD;
               or products containing any of these from 48 hours prior to study drug administration&#xD;
               until discharge from the clinical research unit (CRU).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has a history of clinically significant acute illness or surgery within the previous 3&#xD;
               months prior to Screening Visit or Day -1.&#xD;
  &#xD;
            -  Has a known history of clinically significant hypersensitivity reaction or anaphylaxis&#xD;
               to any medication.&#xD;
  &#xD;
            -  Has any condition possibly affecting drug absorption (e.g., previous surgery on the&#xD;
               gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall&#xD;
               bladder, or pancreas]). History of uncomplicated appendectomy ≥1 year prior to&#xD;
               Screening Visit would not be considered exclusionary at the discretion of the&#xD;
               Investigator.&#xD;
  &#xD;
            -  Is unable to swallow the dosage forms.&#xD;
  &#xD;
            -  Has received any other investigational medicinal product or participation in another&#xD;
               investigational clinical study that included drug treatment within 30 days prior to&#xD;
               Day 1 dose (based on the timing of the last Follow-up Visit for the previous study to&#xD;
               Day 1 of the current study).&#xD;
  &#xD;
          [Note: Other inclusion and exclusion criteria as per protocol may apply.]&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Medpace</last_name>
      <phone>866-872-2349</phone>
      <email>recruitment@medpace.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Casey Witt</last_name>
      <phone>857-242-1540</phone>
      <email>cwitt@sperotherapeutics.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Medpace Clinical Pharmacology Unit</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45227</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Azithromycin</mesh_term>
      <mesh_term>Ethambutol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966688
  org study id: SPR720-102
  nct id: NCT05966688
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The primary purpose of this study is to evaluate the pharmacokinetics (PK) of SPR720,
        azithromycin, and ethambutol, administered separately and co-administered, in healthy adult
        participants.
  allocation: N/A
  intervention model: Sequential Assignment
  intervention model description: It is anticipated that participants will enroll one after another in each arm of this study.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Maximum Observed Plasma Concentration (Cmax) of Study Drug
  time frame: Pre-dose and at multiple time points post-dose up to Day 8
  measure: Time to Attain Maximum Plasma Concentration (tmax) for Study Drug
  time frame: Pre-dose and at multiple time points post-dose up to Day 8
  measure: Area Under the Concentration-time Curve From Time Zero to Dosing Interval (AUC0-τ) for Study Drug
  time frame: Pre-dose and at multiple time points post-dose up to Day 8
  measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
  time frame: From the first dose of study drug through follow-up Day 13
  arm group label: SPR720 1000 mg
  arm group type: Experimental
  description: Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days.
  arm group label: Azithromycin 500 mg
  arm group type: Experimental
  description: Healthy participants will receive azithromycin 500 mg, orally, QD for 7 days.
  arm group label: Ethambutol 800 mg
  arm group type: Experimental
  description: Healthy participants will receive ethambutol 800 mg, orally, QD for 7 days.
  arm group label: SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg
  arm group type: Experimental
  description: Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.
  intervention type: Drug
  intervention name: SPR720
  description: Multiple oral doses of SPR720 capsules.
  arm group label: SPR720 1000 mg
  arm group label: SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg
  intervention type: Drug
  intervention name: Azithromycin
  description: Multiple oral doses of azithromycin.
  arm group label: Azithromycin 500 mg
  arm group label: SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg
  intervention type: Drug
  intervention name: Ethambutol
  description: Multiple oral doses of ethambutol.
  arm group label: Ethambutol 800 mg
  arm group label: SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Medpace
  phone: 866-872-2349
  email: recruitment@medpace.com
  last name: Casey Witt
  phone: 857-242-1540
  email: cwitt@sperotherapeutics.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Azithromycin
  mesh term: Ethambutol
  sharing ipd: No