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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 1 mg glepaglutide once daily, given as single SC injections on Days 1 to 7 |
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| Group B | Experimental | 5 mg glepaglutide once daily, given as single SC injections on Days 1 to 7 |
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| Group C | Experimental | 5 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36 |
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| Group D | Experimental | 10 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36 |
|
| Group E | Experimental | 1 mg glepaglutide, given as an IV infusion at a rate of 4 mg/h for 15 minutes on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glepaglutide | Drug | Solution for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter - half life | Half life of glepaglutide and active metabolites | Day 0 up to Day 73 |
| Pharmacokinetic parameter - total body clearance | Total body clearance after IV administration | Day 0 to Day 22 |
| Pharmacokinetic parameter - Apparent clearance | CL/F for subcutaneous doses | Day 0 to Day 73 |
| Pharmacokinetic parameter - Volume of distribution | Volume of distribution after IV dosing | Day 0- Day 22 |
| Pharmacokinetic parameter - apparent volume of distribution | Vss/F and Vz/F for subcutaneous doses | Day 0 to Day 73 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter - Cmax | Maximum observed plasma concentration | Day 0 to Day 73 |
| Pharmacokinetic parameter - tmax | time of maximum observed plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance CRU | Dallas | Texas | 75247 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36323988 | Derived | Agersnap MA, Sonne K, Knudsen KM, Knudsen CB, Berner-Hansen M. Pharmacokinetics of Glepaglutide, A Long-Acting Glucagon-Like Peptide-2 Analogue: A Study in Healthy Subjects. Clin Drug Investig. 2022 Dec;42(12):1093-1100. doi: 10.1007/s40261-022-01210-1. Epub 2022 Nov 2. |
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| Day 0 to Day 73 |
| Pharmacokinetic parameter - AUC | Area under the curve | Day 0 to Day 73 |
| Pharmacodynamic parameter - plasma citrulline levels | change in plasma citrulline levels | Day 0 to Day 73 |
| ADA incidence | Overall incidence of anti-glepaglutide antibodies | Day 0 to Day 73 |
| Safety and tolerability - AEs | Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions | Day 0 to Day 73 |
| Safety and tolerability - ECGs | 12 lead electrocardiogram parameters | Day 0 to Day 73 |