Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT03279302
Status:
COMPLETED
Last Update Posted:
2017-12-22
First Post:
2017-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-21', 'studyFirstSubmitDate': '2017-09-05', 'studyFirstSubmitQcDate': '2017-09-08', 'lastUpdatePostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameter - half life', 'timeFrame': 'Day 0 up to Day 73', 'description': 'Half life of glepaglutide and active metabolites'}, {'measure': 'Pharmacokinetic parameter - total body clearance', 'timeFrame': 'Day 0 to Day 22', 'description': 'Total body clearance after IV administration'}, {'measure': 'Pharmacokinetic parameter - Apparent clearance', 'timeFrame': 'Day 0 to Day 73', 'description': 'CL/F for subcutaneous doses'}, {'measure': 'Pharmacokinetic parameter - Volume of distribution', 'timeFrame': 'Day 0- Day 22', 'description': 'Volume of distribution after IV dosing'}, {'measure': 'Pharmacokinetic parameter - apparent volume of distribution', 'timeFrame': 'Day 0 to Day 73', 'description': 'Vss/F and Vz/F for subcutaneous doses'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameter - Cmax', 'timeFrame': 'Day 0 to Day 73', 'description': 'Maximum observed plasma concentration'}, {'measure': 'Pharmacokinetic parameter - tmax', 'timeFrame': 'Day 0 to Day 73', 'description': 'time of maximum observed plasma concentration'}, {'measure': 'Pharmacokinetic parameter - AUC', 'timeFrame': 'Day 0 to Day 73', 'description': 'Area under the curve'}, {'measure': 'Pharmacodynamic parameter - plasma citrulline levels', 'timeFrame': 'Day 0 to Day 73', 'description': 'change in plasma citrulline levels'}, {'measure': 'ADA incidence', 'timeFrame': 'Day 0 to Day 73', 'description': 'Overall incidence of anti-glepaglutide antibodies'}, {'measure': 'Safety and tolerability - AEs', 'timeFrame': 'Day 0 to Day 73', 'description': 'Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions'}, {'measure': 'Safety and tolerability - ECGs', 'timeFrame': 'Day 0 to Day 73', 'description': '12 lead electrocardiogram parameters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '36323988', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nGlepaglutide is a proposed International Nonproprietary Name for ZP1848'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations\n* Body Mass index between 18 and 30.0 kg/m2\n* Able to comply with all the trial procedures\n* females will not be pregnant or lactating\n* If female of childbearing potential or male agree to use contraception as defined in the protocol\n* Male subjects must also be willing to refrain from donating sperm from trial Check-in until 90 days after the last dose\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance\n* 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).\n* Clinically significant abnormality on 12-lead ECG\n* Clinically significant abnormality in hematology, clinical chemistry, or urinalysis\n* History of alcoholism or drug/chemical abuse within 2 years\n* Alcohol consumption of \\> 21 units per week for males and \\> 14 units for females\n* Positive urine drug screen\n* Positive hepatitis panel and/or positive human immunodeficiency test\n* Receipt of any investigational product within 30 days or 5 half-lives\n* Previous exposure to GLP-1, GLP-2, human growth hormone, or analogs thereof 30 days prior to Check-in\n* 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\n* 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\n* Receipt of blood products within 2 months prior to Check-in and throughout the trial.\n* 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.\n* Poor peripheral venous access."}, 'identificationModule': {'nctId': 'NCT03279302', 'briefTitle': 'Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zealand Pharma'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ZP1848-16182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': '1 mg glepaglutide once daily, given as single SC injections on Days 1 to 7', 'interventionNames': ['Drug: Glepaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': '5 mg glepaglutide once daily, given as single SC injections on Days 1 to 7', 'interventionNames': ['Drug: Glepaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': '5 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36', 'interventionNames': ['Drug: Glepaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'description': '10 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36', 'interventionNames': ['Drug: Glepaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Group E', 'description': '1 mg glepaglutide, given as an IV infusion at a rate of 4 mg/h for 15 minutes on Day 1', 'interventionNames': ['Drug: Glepaglutide']}], 'interventions': [{'name': 'Glepaglutide', 'type': 'DRUG', 'otherNames': ['ZP1848'], 'description': 'Solution for injection', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D', 'Group E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance CRU', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}