DRUG
Glepaglutide
Solution for injection
Status
Completed
Phase
Phase 1
Enrollment
75
Locations
1
Results
Not posted
Publications
1
Study 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
Interventions
DRUG
Solution for injection
Timeline
First posted
Sep 12, 2017
Study start
Sep 4, 2017
Primary completion
Dec 18, 2017
Study completion
Dec 18, 2017
Results posted
Not reported
Registry updated
Dec 22, 2017
Outcomes
Pharmacokinetic parameter - half life
Time frame · Day 0 up to Day 73
Half life of glepaglutide and active metabolites
Pharmacokinetic parameter - total body clearance
Time frame · Day 0 to Day 22
Total body clearance after IV administration
Pharmacokinetic parameter - Apparent clearance
Time frame · Day 0 to Day 73
CL/F for subcutaneous doses
Pharmacokinetic parameter - Volume of distribution
Time frame · Day 0- Day 22
Volume of distribution after IV dosing
Pharmacokinetic parameter - apparent volume of distribution
Time frame · Day 0 to Day 73
Vss/F and Vz/F for subcutaneous doses
Pharmacokinetic parameter - Cmax
Time frame · Day 0 to Day 73
Maximum observed plasma concentration
Pharmacokinetic parameter - tmax
Time frame · Day 0 to Day 73
time of maximum observed plasma concentration
Pharmacokinetic parameter - AUC
Time frame · Day 0 to Day 73
Area under the curve
Pharmacodynamic parameter - plasma citrulline levels
Time frame · Day 0 to Day 73
change in plasma citrulline levels
ADA incidence
Time frame · Day 0 to Day 73
Overall incidence of anti-glepaglutide antibodies
Safety and tolerability - AEs
Time frame · Day 0 to Day 73
Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions
Safety and tolerability - ECGs
Time frame · Day 0 to Day 73
12 lead electrocardiogram parameters
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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Covance CRU
Dallas, Texas, United States
Publications
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