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

Zealand Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Glepaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03279302

ZP1848-16182

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 5 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: Glepaglutide

Group B

Experimental group

Description:

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

Treatment:

Drug: Glepaglutide

Group C

Experimental group

Description:

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

Treatment:

Drug: Glepaglutide

Group D

Experimental group

Description:

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

Treatment:

Drug: Glepaglutide

Group E

Experimental group

Description:

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

Treatment:

Drug: Glepaglutide