Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects

NCT ID: NCT03279302

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-04
• Study Completion Date: 2017-12-18

Brief Summary

The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy subjects.

Glepaglutide is a proposed International Nonproprietary Name for ZP1848

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

1 mg glepaglutide once daily, given as single SC injections on Days 1 to 7

Group Type: EXPERIMENTAL

Glepaglutide

Intervention Type: DRUG

Solution for injection

Group B

5 mg glepaglutide once daily, given as single SC injections on Days 1 to 7

Group Type: EXPERIMENTAL

Glepaglutide

Intervention Type: DRUG

Solution for injection

Group C

5 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36

Group Type: EXPERIMENTAL

Glepaglutide

Intervention Type: DRUG

Solution for injection

Group D

10 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36

Group Type: EXPERIMENTAL

Glepaglutide

Intervention Type: DRUG

Solution for injection

Group E

1 mg glepaglutide, given as an IV infusion at a rate of 4 mg/h for 15 minutes on Day 1

Group Type: EXPERIMENTAL

Glepaglutide

Intervention Type: DRUG

Solution for injection

Interventions

Glepaglutide

Solution for injection

Intervention Type: DRUG

Other Intervention Names

ZP1848

Eligibility Criteria

Inclusion Criteria

• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
• Body Mass index between 18 and 30.0 kg/m2
• Able to comply with all the trial procedures
• females will not be pregnant or lactating
• If female of childbearing potential or male agree to use contraception as defined in the protocol
• Male subjects must also be willing to refrain from donating sperm from trial Check-in until 90 days after the last dose

Exclusion Criteria

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
• History of bowel obstruction, stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and/or cholecystectomy or hernia repair will be allowed).
• Clinically significant abnormality on 12-lead ECG
• Clinically significant abnormality in hematology, clinical chemistry, or urinalysis
• History of alcoholism or drug/chemical abuse within 2 years
• Alcohol consumption of > 21 units per week for males and > 14 units for females
• Positive urine drug screen
• Positive hepatitis panel and/or positive human immunodeficiency test
• Receipt of any investigational product within 30 days or 5 half-lives
• Previous exposure to GLP-1, GLP-2, human growth hormone, or analogs thereof 30 days prior to Check-in
• Use or intend to use any medications/products known to be strong inhibitors or strong inducers of cytochrome P450 3A enzyme, including St. John's wort
• Use of tobacco, smoking cessation products, or products containing nicotine (including but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine lozenges, or nicotine gum ) within 3 months prior to Screening
• Receipt of blood products within 2 months prior to Check-in and throughout the trial.
• Donation of blood or significant blood loss from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening and throughout the trial.
• Poor peripheral venous access.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zealand Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance CRU

Dallas, Texas, United States

Countries

United States

References

Agersnap MA, Sonne K, Knudsen KM, Knudsen CB, Berner-Hansen M. Pharmacokinetics of Glepaglutide, A Long-Acting Glucagon-Like Peptide-2 Analogue: A Study in Healthy Subjects. Clin Drug Investig. 2022 Dec;42(12):1093-1100. doi: 10.1007/s40261-022-01210-1. Epub 2022 Nov 2.

Reference Type: DERIVED

PMID: 36323988 (View on PubMed)

Other Identifiers

ZP1848-16182

Identifier Type: -

Identifier Source: org_study_id