Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 12/24/2017 |
Start Date: | September 4, 2017 |
End Date: | December 18, 2017 |
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
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
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
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.
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