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

Healthy Subjects Clinical Trial

Official title:

A Phase 1, Open-Label, Partially Randomized, 3-Part, Parallel Group Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide (ZP1848) After a Single Intravenous Injection and After Multiple Subcutaneous Injections in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279302
• Other study ID #: ZP1848-16182
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2017
• Last updated: December 21, 2017
• Start date: September 4, 2017
• Est. completion date: December 18, 2017

Study information

• Verified date: December 2017
• Source: Zealand Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Glepaglutide
Solution for injection

Locations

Country	Name	City	State
United States	Covance CRU	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Zealand Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameter - half life	Half life of glepaglutide and active metabolites	Day 0 up to Day 73
Primary	Pharmacokinetic parameter - total body clearance	Total body clearance after IV administration	Day 0 to Day 22
Primary	Pharmacokinetic parameter - Apparent clearance	CL/F for subcutaneous doses	Day 0 to Day 73
Primary	Pharmacokinetic parameter - Volume of distribution	Volume of distribution after IV dosing	Day 0- Day 22
Primary	Pharmacokinetic parameter - apparent volume of distribution	Vss/F and Vz/F for subcutaneous doses	Day 0 to Day 73
Secondary	Pharmacokinetic parameter - Cmax	Maximum observed plasma concentration	Day 0 to Day 73
Secondary	Pharmacokinetic parameter - tmax	time of maximum observed plasma concentration	Day 0 to Day 73
Secondary	Pharmacokinetic parameter - AUC	Area under the curve	Day 0 to Day 73
Secondary	Pharmacodynamic parameter - plasma citrulline levels	change in plasma citrulline levels	Day 0 to Day 73
Secondary	ADA incidence	Overall incidence of anti-glepaglutide antibodies	Day 0 to Day 73
Secondary	Safety and tolerability - AEs	Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions	Day 0 to Day 73
Secondary	Safety and tolerability - ECGs	12 lead electrocardiogram parameters	Day 0 to Day 73