Status:
COMPLETED
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
Lead Sponsor:
Zealand Pharma
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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) inject...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2017
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03279302
Start Date
September 4 2017
End Date
December 18 2017
Last Update
December 22 2017
Active Locations (1)
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1
Covance CRU
Dallas, Texas, United States, 75247