A Phase 1 interventional study of Glepaglutide in Healthy Subjects, sponsored by Zealand Pharma. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by Zealand Pharma · Phase 1, Interventional, and Treatment
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
Exclusion Criteria:
1 mg glepaglutide once daily, given as single SC injections on Days 1 to 7
Drug: Glepaglutide
5 mg glepaglutide once daily, given as single SC injections on Days 1 to 7
Drug: Glepaglutide
5 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36
Drug: Glepaglutide
10 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36
Drug: Glepaglutide
1 mg glepaglutide, given as an IV infusion at a rate of 4 mg/h for 15 minutes on Day 1
Drug: Glepaglutide
Solution for injection
Also known as: ZP1848
Pharmacokinetic parameter - half life
Half life of glepaglutide and active metabolites
Time frame: Day 0 up to Day 73
Pharmacokinetic parameter - total body clearance
Total body clearance after IV administration
Time frame: Day 0 to Day 22
Pharmacokinetic parameter - Apparent clearance
CL/F for subcutaneous doses
Time frame: Day 0 to Day 73
Pharmacokinetic parameter - Volume of distribution
Volume of distribution after IV dosing
Time frame: Day 0- Day 22
Pharmacokinetic parameter - apparent volume of distribution
Vss/F and Vz/F for subcutaneous doses
Time frame: Day 0 to Day 73
Pharmacokinetic parameter - Cmax
Maximum observed plasma concentration
Time frame: Day 0 to Day 73
Pharmacokinetic parameter - tmax
time of maximum observed plasma concentration
Time frame: Day 0 to Day 73
Pharmacokinetic parameter - AUC
Area under the curve
Time frame: Day 0 to Day 73
Pharmacodynamic parameter - plasma citrulline levels
change in plasma citrulline levels
Time frame: Day 0 to Day 73
ADA incidence
Overall incidence of anti-glepaglutide antibodies
Time frame: Day 0 to Day 73
Safety and tolerability - AEs
Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions
Time frame: Day 0 to Day 73
Safety and tolerability - ECGs
12 lead electrocardiogram parameters
Time frame: Day 0 to Day 73
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Zealand Pharma