<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/NCT03031535</url>
  </required_header>
  <id_info>
    <org_study_id>DP1038-PK-101</org_study_id>
    <nct_id>NCT03031535</nct_id>
  </id_info>
  <brief_title>Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers</brief_title>
  <official_title>A Two-Part, Phase 1, Randomized, Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intranasal Octreotide (DP1038) Versus Subcutaneous Sandostatin® Injection in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dauntless Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dauntless Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the drug octreotide acetate in a new intranasal&#xD;
      formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation. The&#xD;
      two octreotide acetate formulations will be evaluated following separate administrations for&#xD;
      safety and tolerability including any side effects, the speed at which the drug is absorbed&#xD;
      and eliminated in the body, and the ability of the drug to lower the levels of growth hormone&#xD;
      (GH) and insulin-like growth factor 1 (IGF-1).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Octreotide is a synthetic octapeptide analog of naturally occurring somatostatin, with&#xD;
      similar pharmacological effects but a longer duration of action. It inhibits the pathological&#xD;
      secretion of GH from pituitary adenomas, and of serotonin and other hormones by tumors of the&#xD;
      gastroenteropancreatic endocrine system. Currently, only injectable octreotide and&#xD;
      somatostatin analogs have been approved, for the indications of acromegaly, carcinoid tumors,&#xD;
      and vasoactive intestinal peptide tumors.&#xD;
&#xD;
      DP1038, an intranasal formulation of octreotide, is being developed for the treatment of&#xD;
      acromegaly, a rare chronic disorder arising from the overproduction of GH, predominantly by&#xD;
      pituitary adenomas. Excess GH and associated IGF-1 levels are responsible for multiple&#xD;
      symptoms (e.g., headache, tissue swelling, perspiration, joint pain) and significant&#xD;
      comorbidities (e.g., diabetes, sleep apnea, cardiovascular abnormalities such as&#xD;
      hypertension). In most patients with acromegaly, octreotide consistently normalizes GH and&#xD;
      IGF-1 serum concentrations, thereby markedly reducing clinical symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 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>Crossover Assignment</intervention_model>
    <intervention_model_description>This study consists of two study parts. In Study Part 1, 12 subject will be randomized into one of four study arms using a 4x4 modified latin square design.&#xD;
In Study Part 2, subjects will be randomized into one of two arms using a 2x2 crossover design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of subjects reporting adverse events (AEs)/serious adverse events (SAEs).</measure>
    <time_frame>Both Study Parts: Entire study duration, an average of 1 week.</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC)</measure>
    <time_frame>Part 1 - Days 1, 3, 5, and 7 &amp; Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.</time_frame>
    <description>AUC from pre-dose to time 't' (AUC[0-t]) and pre-dose to infinite time (AUC[0-infinity]) of intranasal DP1038 versus subcutaneous Sandostatin Injection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>Part 1 - Days 1, 3, 5, and 7 &amp; Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.</time_frame>
    <description>Maximum octreotide plasma concentration (Cmax) of intranasal DP1038 versus subcutaneous Sandostatin Injection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration (Tmax)</measure>
    <time_frame>Part 1 - Days 1, 3, 5, and 7 &amp; Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.</time_frame>
    <description>Time to maximum octreotide plasma concentration (Tmax) of intranasal DP1038 versus subcutaneous Sandostatin Injection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lagtime (Tlag)</measure>
    <time_frame>Part 1 - Days 1, 3, 5, and 7 &amp; Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.</time_frame>
    <description>Tlag is the amount of time required to obtain the first measurable concentration of plasma octreotide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination half-life (t1/2)</measure>
    <time_frame>Part 1 - Days 1, 3, 5, and 7 &amp; Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.</time_frame>
    <description>Plasma decay half-life is the time measured for the octreotide plasma concentration to decrease by one half.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent systemic clearance (CL/F)</measure>
    <time_frame>Part 1 - Days 1, 3, 5, and 7 &amp; Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.</time_frame>
    <description>CL/F is the volume of plasma cleared of octreotide per unit time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination rate constant (lambda z)</measure>
    <time_frame>Part 1 - Days 1, 3, 5, and 7 &amp; Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.</time_frame>
    <description>Lambda z is a quantitative measure of the rate at which octreotide is removed from the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution (Vz/F)</measure>
    <time_frame>Part 1 - Days 1, 3, 5, and 7 &amp; Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.</time_frame>
    <description>Vz/F is the apparent volume of distribution of octreotide during the terminal elimination phase not corrected for bioavailability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth hormone (GH) concentrations over time.</measure>
    <time_frame>Part 2 only - Days 1, 3, and 5: -60 min, -40 min, -20 min, and -5 min pre-dose and post-arginine infusion completion at 0 min, 20 min, 40 min, 60 min, 80 min, 100 min, 120 min, 140 min, and 160 min, and at 4 and 8 hr.</time_frame>
    <description>GH levels will be collected over time to compare the suppressive ability of intranasal octreotide (DP1038) versus subcutaneous octreotide (Sandostatin Injection) compared to no octreotide on the GH levels after a GHRH/arginine challenge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin-like growth factor-1 (IGF-1) concentrations over time.</measure>
    <time_frame>Part 2 only - Days 1, 3, and 5: -60 min, -40 min, -20 min, and -5 min pre-dose and post-arginine infusion completion at 0 min, 20 min, 40 min, 60 min, 80 min, 100 min, 120 min, 140 min, and 160 min, and at 4 and 8 hr.</time_frame>
    <description>IGF-1 levels will be collected over time to compare the suppressive ability of intranasal octreotide (DP1038) versus subcutaneous octreotide (Sandostatin Injection) compared to no octreotide on IGF-1 levels after a GHRH/arginine challenge.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy Volunteer Study</condition>
  <arm_group>
    <arm_group_label>Study Part 1 - Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 - Intranasal octreotide acetate (DP1038) - 400 micrograms; Day 3 - Intranasal octreotide acetate (DP1038) - 1200 micrograms; Day 5 - Intranasal octreotide acetate (DP1038) - 2000 micrograms; Day 7 - Subcutaneous octreotide acetate (Sandostatin Injection) - 100 micrograms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Part 1 - Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 - Intranasal octreotide acetate (DP1038) - 1200 micrograms; Day 3 - Intranasal octreotide acetate (DP1038) - 400 micrograms; Day 5 - Subcutaneous octreotide acetate (Sandostatin Injection) - 100 micrograms; Day 7 - Intranasal octreotide acetate (DP1038) - 2000 micrograms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Part 1 - Arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 - Intranasal octreotide acetate (DP1038) - 2000 micrograms; Day 3 - Subcutaneous octreotide acetate (Sandostatin Injection) - 100 micrograms; Day 5 - Intranasal octreotide acetate (DP1038) - 400 micrograms; Day 7 - Intranasal octreotide acetate (DP1038) - 1200 micrograms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Part 1 - Arm 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 - Subcutaneous octreotide acetate (Sandostatin Injection) - 100 micrograms; Day 3 - Intranasal octreotide acetate (DP1038) - 2000 micrograms; Day 5 - Intranasal octreotide acetate (DP1038) - 1200 micrograms; Day 7 - Intranasal octreotide acetate (DP1038) - 400 micrograms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Part 2 - Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 - 1 microgram/kilogram of growth hormone-releasing hormone (GHRH) + 30 grams arginine hydrochloride; Day 3 - Intranasal octreotide acetate (DP1038) - dose to be determined from Study Part 1 PK results + 1 microgram/kilogram of GHRH + 30 grams arginine hydrochloride; Day 5 - SC octreotide acetate (Sandostatin Injection) 100 micrograms + 1 microgram/kilogram of GHRH + 30 grams arginine hydrochloride.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Part 2 - Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 - 1 microgram/kilogram of GHRH + 30 grams arginine hydrochloride; Day 3 - SC octreotide acetate (Sandostatin Injection) 100 micrograms + 1 microgram/kilogram of GHRH + 30 grams arginine hydrochloride; Day 5 - Intranasal octreotide acetate (DP1038) - dose to be determined from Study Part 1 PK results + 1 microgram/kilogram of GHRH + 30 grams arginine hydrochloride.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal octreotide acetate</intervention_name>
    <description>Intranasal spray of octreotide acetate</description>
    <arm_group_label>Study Part 1 - Arm 1</arm_group_label>
    <arm_group_label>Study Part 1 - Arm 2</arm_group_label>
    <arm_group_label>Study Part 1 - Arm 3</arm_group_label>
    <arm_group_label>Study Part 1 - Arm 4</arm_group_label>
    <arm_group_label>Study Part 2 - Arm 1</arm_group_label>
    <arm_group_label>Study Part 2 - Arm 2</arm_group_label>
    <other_name>DP1038</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Subcutaneous octreotide acetate</intervention_name>
    <description>Subcutaneous injectable solution of octreotide acetate</description>
    <arm_group_label>Study Part 1 - Arm 1</arm_group_label>
    <arm_group_label>Study Part 1 - Arm 2</arm_group_label>
    <arm_group_label>Study Part 1 - Arm 3</arm_group_label>
    <arm_group_label>Study Part 1 - Arm 4</arm_group_label>
    <arm_group_label>Study Part 2 - Arm 1</arm_group_label>
    <arm_group_label>Study Part 2 - Arm 2</arm_group_label>
    <other_name>Sandostatin Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Growth hormone-releasing hormone</intervention_name>
    <description>Part of the well established GHRH/Arginine challenge to detect GH deficiency.</description>
    <arm_group_label>Study Part 2 - Arm 1</arm_group_label>
    <arm_group_label>Study Part 2 - Arm 2</arm_group_label>
    <other_name>GHRH</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Arginine hydrochloride</intervention_name>
    <description>Part of the well established GHRH/Arginine challenge to detect GH deficiency.</description>
    <arm_group_label>Study Part 2 - Arm 1</arm_group_label>
    <arm_group_label>Study Part 2 - Arm 2</arm_group_label>
    <other_name>R-Gene 10</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key eligibility criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) 18 and &lt;28 kg/m2 (to minimize variability in SC absorption).&#xD;
&#xD;
          -  Be in good general health.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any tobacco product within 30 days prior to first dose of study drug.&#xD;
&#xD;
          -  Use of any prescription or non-prescription drugs or dietary supplements within 7&#xD;
             days, insulin or hypoglycemic drugs within 3 months, estrogen-containing medication&#xD;
             within 3 months, or drugs that may affect GH and IGF-1 levels (e.g., alpha-adrenergic,&#xD;
             beta-adrenergic, and cholinergic drugs) within 1 month prior to dosing.&#xD;
&#xD;
          -  Subjects will also be excluded if they have a history of gallbladder disease,&#xD;
             hypothyroidism, or unexplained hypoglycemia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Zacher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Celerion</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion, Inc.</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>May 11, 2017</last_update_submitted>
  <last_update_submitted_qc>May 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</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>Octreotide</mesh_term>
    <mesh_term>Hormones</mesh_term>
    <mesh_term>Growth Hormone-Releasing Hormone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03031535
org study id: DP1038-PK-101
nct id: NCT03031535
lead sponsor: 
has dmc: No
The purpose of the study is to investigate the drug octreotide acetate in a new intranasal
      formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation. The
      two octreotide acetate formulations will be evaluated following separate administrations for
      safety and tolerability including any side effects, the speed at which the drug is absorbed
      and eliminated in the body, and the ability of the drug to lower the levels of growth hormone
      (GH) and insulin-like growth factor 1 (IGF-1).
Octreotide is a synthetic octapeptide analog of naturally occurring somatostatin, with
      similar pharmacological effects but a longer duration of action. It inhibits the pathological
      secretion of GH from pituitary adenomas, and of serotonin and other hormones by tumors of the
      gastroenteropancreatic endocrine system. Currently, only injectable octreotide and
      somatostatin analogs have been approved, for the indications of acromegaly, carcinoid tumors,
      and vasoactive intestinal peptide tumors.

      DP1038, an intranasal formulation of octreotide, is being developed for the treatment of
      acromegaly, a rare chronic disorder arising from the overproduction of GH, predominantly by
      pituitary adenomas. Excess GH and associated IGF-1 levels are responsible for multiple
      symptoms (e.g., headache, tissue swelling, perspiration, joint pain) and significant
      comorbidities (e.g., diabetes, sleep apnea, cardiovascular abnormalities such as
      hypertension). In most patients with acromegaly, octreotide consistently normalizes GH and
      IGF-1 serum concentrations, thereby markedly reducing clinical symptoms.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study consists of two study parts. In Study Part 1, 12 subject will be randomized into one of four study arms using a 4x4 modified latin square design.
In Study Part 2, subjects will be randomized into one of two arms using a 2x2 crossover design.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of subjects reporting adverse events (AEs)/serious adverse events (SAEs).
time frame: Both Study Parts: Entire study duration, an average of 1 week.
description: An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE.
measure: Area under the plasma concentration-time curve (AUC)
time frame: Part 1 - Days 1, 3, 5, and 7 & Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.
description: AUC from pre-dose to time 't' (AUC[0-t]) and pre-dose to infinite time (AUC[0-infinity]) of intranasal DP1038 versus subcutaneous Sandostatin Injection.
measure: Maximum plasma concentration (Cmax)
time frame: Part 1 - Days 1, 3, 5, and 7 & Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.
description: Maximum octreotide plasma concentration (Cmax) of intranasal DP1038 versus subcutaneous Sandostatin Injection.
measure: Time to maximum plasma concentration (Tmax)
time frame: Part 1 - Days 1, 3, 5, and 7 & Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.
description: Time to maximum octreotide plasma concentration (Tmax) of intranasal DP1038 versus subcutaneous Sandostatin Injection.
measure: Lagtime (Tlag)
time frame: Part 1 - Days 1, 3, 5, and 7 & Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.
description: Tlag is the amount of time required to obtain the first measurable concentration of plasma octreotide.
measure: Terminal elimination half-life (t1/2)
time frame: Part 1 - Days 1, 3, 5, and 7 & Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.
description: Plasma decay half-life is the time measured for the octreotide plasma concentration to decrease by one half.
measure: Apparent systemic clearance (CL/F)
time frame: Part 1 - Days 1, 3, 5, and 7 & Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.
description: CL/F is the volume of plasma cleared of octreotide per unit time.
measure: Elimination rate constant (lambda z)
time frame: Part 1 - Days 1, 3, 5, and 7 & Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.
description: Lambda z is a quantitative measure of the rate at which octreotide is removed from the body.
measure: Apparent volume of distribution (Vz/F)
time frame: Part 1 - Days 1, 3, 5, and 7 & Part 2 - Days 3 and 5: Pre-dose, 5 min, 10 min, 20 min, 30 min, 40 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose.
description: Vz/F is the apparent volume of distribution of octreotide during the terminal elimination phase not corrected for bioavailability.
measure: Growth hormone (GH) concentrations over time.
time frame: Part 2 only - Days 1, 3, and 5: -60 min, -40 min, -20 min, and -5 min pre-dose and post-arginine infusion completion at 0 min, 20 min, 40 min, 60 min, 80 min, 100 min, 120 min, 140 min, and 160 min, and at 4 and 8 hr.
description: GH levels will be collected over time to compare the suppressive ability of intranasal octreotide (DP1038) versus subcutaneous octreotide (Sandostatin Injection) compared to no octreotide on the GH levels after a GHRH/arginine challenge.
measure: Insulin-like growth factor-1 (IGF-1) concentrations over time.
time frame: Part 2 only - Days 1, 3, and 5: -60 min, -40 min, -20 min, and -5 min pre-dose and post-arginine infusion completion at 0 min, 20 min, 40 min, 60 min, 80 min, 100 min, 120 min, 140 min, and 160 min, and at 4 and 8 hr.
description: IGF-1 levels will be collected over time to compare the suppressive ability of intranasal octreotide (DP1038) versus subcutaneous octreotide (Sandostatin Injection) compared to no octreotide on IGF-1 levels after a GHRH/arginine challenge.
arm group label: Study Part 1 - Arm 1
arm group type: Experimental
description: Day 1 - Intranasal octreotide acetate (DP1038) - 400 micrograms; Day 3 - Intranasal octreotide acetate (DP1038) - 1200 micrograms; Day 5 - Intranasal octreotide acetate (DP1038) - 2000 micrograms; Day 7 - Subcutaneous octreotide acetate (Sandostatin Injection) - 100 micrograms.
arm group label: Study Part 1 - Arm 2
arm group type: Experimental
description: Day 1 - Intranasal octreotide acetate (DP1038) - 1200 micrograms; Day 3 - Intranasal octreotide acetate (DP1038) - 400 micrograms; Day 5 - Subcutaneous octreotide acetate (Sandostatin Injection) - 100 micrograms; Day 7 - Intranasal octreotide acetate (DP1038) - 2000 micrograms.
arm group label: Study Part 1 - Arm 3
arm group type: Experimental
description: Day 1 - Intranasal octreotide acetate (DP1038) - 2000 micrograms; Day 3 - Subcutaneous octreotide acetate (Sandostatin Injection) - 100 micrograms; Day 5 - Intranasal octreotide acetate (DP1038) - 400 micrograms; Day 7 - Intranasal octreotide acetate (DP1038) - 1200 micrograms.
arm group label: Study Part 1 - Arm 4
arm group type: Experimental
description: Day 1 - Subcutaneous octreotide acetate (Sandostatin Injection) - 100 micrograms; Day 3 - Intranasal octreotide acetate (DP1038) - 2000 micrograms; Day 5 - Intranasal octreotide acetate (DP1038) - 1200 micrograms; Day 7 - Intranasal octreotide acetate (DP1038) - 400 micrograms.
arm group label: Study Part 2 - Arm 1
arm group type: Experimental
description: Day 1 - 1 microgram/kilogram of growth hormone-releasing hormone (GHRH) + 30 grams arginine hydrochloride; Day 3 - Intranasal octreotide acetate (DP1038) - dose to be determined from Study Part 1 PK results + 1 microgram/kilogram of GHRH + 30 grams arginine hydrochloride; Day 5 - SC octreotide acetate (Sandostatin Injection) 100 micrograms + 1 microgram/kilogram of GHRH + 30 grams arginine hydrochloride.
arm group label: Study Part 2 - Arm 2
arm group type: Experimental
description: Day 1 - 1 microgram/kilogram of GHRH + 30 grams arginine hydrochloride; Day 3 - SC octreotide acetate (Sandostatin Injection) 100 micrograms + 1 microgram/kilogram of GHRH + 30 grams arginine hydrochloride; Day 5 - Intranasal octreotide acetate (DP1038) - dose to be determined from Study Part 1 PK results + 1 microgram/kilogram of GHRH + 30 grams arginine hydrochloride.
intervention type: Drug
intervention name: Intranasal octreotide acetate
description: Intranasal spray of octreotide acetate
arm group label: Study Part 1 - Arm 1
arm group label: Study Part 1 - Arm 2
arm group label: Study Part 1 - Arm 3
arm group label: Study Part 1 - Arm 4
arm group label: Study Part 2 - Arm 1
arm group label: Study Part 2 - Arm 2
other name: DP1038
intervention type: Drug
intervention name: Subcutaneous octreotide acetate
description: Subcutaneous injectable solution of octreotide acetate
arm group label: Study Part 1 - Arm 1
arm group label: Study Part 1 - Arm 2
arm group label: Study Part 1 - Arm 3
arm group label: Study Part 1 - Arm 4
arm group label: Study Part 2 - Arm 1
arm group label: Study Part 2 - Arm 2
other name: Sandostatin Injection
intervention type: Diagnostic Test
intervention name: Growth hormone-releasing hormone
description: Part of the well established GHRH/Arginine challenge to detect GH deficiency.
arm group label: Study Part 2 - Arm 1
arm group label: Study Part 2 - Arm 2
other name: GHRH
intervention type: Diagnostic Test
intervention name: Arginine hydrochloride
description: Part of the well established GHRH/Arginine challenge to detect GH deficiency.
arm group label: Study Part 2 - Arm 1
arm group label: Study Part 2 - Arm 2
other name: R-Gene 10
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Zacher, MD
role: Principal Investigator
affiliation: Celerion
facility: 
country: United States
responsible party type: Sponsor
mesh term: Octreotide
mesh term: Hormones
mesh term: Growth Hormone-Releasing Hormone
sharing ipd: No