Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04532567
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2020-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Healthy Japanese and Caucasian Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722907', 'term': 'GLPG1205'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation', 'timeFrame': 'From screening through study completion, an average of 3 months', 'description': 'To evaluate the safety and tolerability of single and multiple oral doses of GLPG1205 in healthy male Japanese and Caucasian subjects'}, {'measure': 'Maximum observed plasma concentration (Cmax) of GLPG1205', 'timeFrame': 'Between Day 1 pre-dose and Day 18 and at follow-up Day 32', 'description': 'To assess the PK of single and multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects'}, {'measure': 'Area under the plasma concentration-time curve from time zero till 24 hours postdose (AUC 0-24h) of GLPG1205', 'timeFrame': 'Between Day 1 pre-dose and Day 18 and at follow-up Day 32', 'description': 'To assess the PK of single oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects'}, {'measure': 'Area under the plasma concentration-time curve over the dosing interval (AUC T) of GLPG1205', 'timeFrame': 'Between Day 1 pre-dose and Day 18 and at follow-up Day 32', 'description': 'To assess the PK of multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to assess the safety and tolerability of GLPG1205 in single and multiple oral doses in healthy male Caucasian and Japanese subjects. This study will also assess the pharmacokinetics (PK) across different doses of GLPG1205. PK will look at how the study drug is absorbed, broken down, and eliminated by your body.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian and Japanese male between 20-55 years of age (extremes included), on the date of signing the informed consent form (ICF).\n* Japanese subjects must be first generation Japanese of full Japanese parentage, and must have not lived outside Japan for more than 5 years. First generation subjects will have been born in Japan of 2 parents and 4 grandparents also born in Japan of full Japanese descent.\n* A body mass index (BMI) between 18-26 kg/m2, extremes included, with a minimum body weight of 45 kg.\n* Able and willing to comply with the protocol requirements and signing the ICF as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.\n\nExclusion Criteria:\n\n* History of serious allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization) and/or known sensitivity to the investigational product (IP) or its excipients as determined by the investigator.\n* Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IP.'}, 'identificationModule': {'nctId': 'NCT04532567', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Healthy Japanese and Caucasian Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of GLPG1205 for 14 Days in Healthy Japanese and Caucasian Male Subjects', 'orgStudyIdInfo': {'id': 'GLPG1205-CL-121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLPG1205 dose A', 'description': 'Participants will receive a single dose with dose A of GLPG1205 on Day 1 in Period 1, and 14 days q.d. dosing on Days 1 to 14 in Period 2.', 'interventionNames': ['Drug: GLPG1205']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo dose A', 'description': 'Participants will receive a single dose placebo on Day 1 in Period 1, and 14 days q.d. dosing on Days 1 to 14 in Period 2.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GLPG1205 dose B', 'description': 'Participants will receive 14 days q.d. dosing with dose B of GLPG1205 on Days 1 to 14.', 'interventionNames': ['Drug: GLPG1205']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo dose B', 'description': 'Participants will receive 14 days q.d. dosing placebo on Days 1 to 14.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GLPG1205', 'type': 'DRUG', 'description': 'GLPG1205 film-coated tablets', 'armGroupLabels': ['GLPG1205 dose A', 'GLPG1205 dose B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo film-coated tablets', 'armGroupLabels': ['Placebo dose A', 'Placebo dose B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'WCCT Global', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}], 'overallOfficials': [{'name': 'Ekaterina Tankisheva, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}