Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers

NCT03031535 | Completed Phase 1

• 1 other identifier: DP1038-PK-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects reporting adverse events (AEs)/serious adverse events (SAEs).

  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.

  Both Study Parts: Entire study duration, an average of 1 week.

Secondary Outcomes (10)

• Area under the plasma concentration-time curve (AUC)

  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.

• Maximum plasma concentration (Cmax)

  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.

• Time to maximum plasma concentration (Tmax)

  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.

• Lagtime (Tlag)

  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.

• Terminal elimination half-life (t1/2)

  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.

Study Arms (6)

Study Part 1 - Arm 1

EXPERIMENTAL

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.

Drug: Intranasal octreotide acetate; Drug: Subcutaneous octreotide acetate

Study Part 1 - Arm 2

EXPERIMENTAL

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.

Drug: Intranasal octreotide acetate; Drug: Subcutaneous octreotide acetate

Study Part 1 - Arm 3

EXPERIMENTAL

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.

Drug: Intranasal octreotide acetate; Drug: Subcutaneous octreotide acetate

Study Part 1 - Arm 4

EXPERIMENTAL

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.

Drug: Intranasal octreotide acetate; Drug: Subcutaneous octreotide acetate

Study Part 2 - Arm 1

EXPERIMENTAL

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.

Drug: Intranasal octreotide acetate; Drug: Subcutaneous octreotide acetate; Diagnostic Test: Growth hormone-releasing hormone; Diagnostic Test: Arginine hydrochloride

Study Part 2 - Arm 2

EXPERIMENTAL

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.

Drug: Intranasal octreotide acetate; Drug: Subcutaneous octreotide acetate; Diagnostic Test: Growth hormone-releasing hormone; Diagnostic Test: Arginine hydrochloride

Interventions

Intranasal octreotide acetate DRUG

Intranasal spray of octreotide acetate

Also known as: DP1038

Study Part 1 - Arm 1; Study Part 1 - Arm 2; Study Part 1 - Arm 3; Study Part 1 - Arm 4; Study Part 2 - Arm 1; Study Part 2 - Arm 2

Subcutaneous octreotide acetate DRUG

Subcutaneous injectable solution of octreotide acetate

Also known as: Sandostatin Injection

Study Part 1 - Arm 1; Study Part 1 - Arm 2; Study Part 1 - Arm 3; Study Part 1 - Arm 4; Study Part 2 - Arm 1; Study Part 2 - Arm 2

Growth hormone-releasing hormone DIAGNOSTIC_TEST

Part of the well established GHRH/Arginine challenge to detect GH deficiency.

Also known as: GHRH

Study Part 2 - Arm 1; Study Part 2 - Arm 2

Arginine hydrochloride DIAGNOSTIC_TEST

Part of the well established GHRH/Arginine challenge to detect GH deficiency.

Also known as: R-Gene 10

Study Part 2 - Arm 1; Study Part 2 - Arm 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) 18 and \<28 kg/m2 (to minimize variability in SC absorption).
• Be in good general health.

You may not qualify if:

• Use of any tobacco product within 30 days prior to first dose of study drug.
• Use of any prescription or non-prescription drugs or dietary supplements within 7 days, insulin or hypoglycemic drugs within 3 months, estrogen-containing medication within 3 months, or drugs that may affect GH and IGF-1 levels (e.g., alpha-adrenergic, beta-adrenergic, and cholinergic drugs) within 1 month prior to dosing.
• Subjects will also be excluded if they have a history of gallbladder disease, hypothyroidism, or unexplained hypoglycemia.

Sponsors & Collaborators

• Dauntless Pharmaceuticals: lead

Study Sites (1)

Celerion, Inc.

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

Octreotide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jeffrey Zacher, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 25, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)