Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT02567695
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2015-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628792', 'term': 'voxelotor'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-10-01', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment-emergent adverse events (TEAEs) and serious adverse events', 'timeFrame': 'Baseline to Period 2 Day 28'}, {'measure': 'Changes in clinical laboratory results', 'timeFrame': 'Baseline to Period 2 Day 28'}, {'measure': 'Changes in physical examination findings', 'timeFrame': 'Baseline to Period 2 Day 28'}, {'measure': 'Changes in vital signs', 'timeFrame': 'Baseline to Period 2 Day 28'}, {'measure': 'Changes in electrocardiograms (ECGs)', 'timeFrame': 'Baseline to Period 2 Day 28'}], 'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum observed concentration (Cmax) of GBT440 in whole blood', 'timeFrame': 'predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period'}, {'measure': 'Pharmacokinetics (PK): Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUCt) of GBT440 in whole blood', 'timeFrame': 'predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period'}, {'measure': 'Pharmacokinetics (PK): AUC from time 0 extrapolated to infinity (AUCinf) of GBT440 in whole blood', 'timeFrame': 'predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): The time that Cmax was observed (tmax) of GBT440 in whole blood', 'timeFrame': 'predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period'}, {'measure': 'Pharmacokinetics (PK): Terminal elimination half-life (t½) of GBT440 in whole blood', 'timeFrame': 'predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period'}, {'measure': 'Pharmacokinetics (PK): Apparent oral clearance (CL/F) of GBT440 in whole blood', 'timeFrame': 'predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period'}, {'measure': 'Pharmacokinetics (PK): Apparent volume of distribution during the terminal phase (Vz/F) of GBT440 in whole blood', 'timeFrame': 'predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100 mg) capsule formulation in healthy fasted subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening\n* Male subjects agree to use contraception\n* Willing and able to give written informed consent\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal,hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder\n* History of hypersensitivity or allergy to drugs, foods, or other substances\n* History or presence of abnormal electrocardiogram or hypertension\n* History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 1 year of screening\n* Participated in another clinical trial of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening'}, 'identificationModule': {'nctId': 'NCT02567695', 'briefTitle': 'A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Global Blood Therapeutics'}, 'officialTitle': 'A Phase 1, Single-Dose, Open-Label, Randomized, Two-Period Crossover Study to Evaluate the Relative Bioavailability of GBT440 300 mg Administered as Capsule Formulations in Healthy Subjects', 'orgStudyIdInfo': {'id': 'GBT440-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence 1', 'description': 'Treatment A with one 300 mg capsule (high-strength) of GBT440 administered in a fasted state (test) in dosing Period 1 followed by Treatment B with 300 mg (3 × 100 mg) capsules (low-strength) of GBT440 administered in a fasted state (reference) in dosing Period 2.', 'interventionNames': ['Drug: GBT440']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence 2', 'description': 'Treatment B with 300 mg (3 × 100 mg) capsules (low-strength) of GBT440 administered in a fasted state (reference) in dosing Period 1 followed by Treatment A with one 300 mg capsule (high-strength) of GBT440 administered in a fasted state (test) in dosing Period 2.', 'interventionNames': ['Drug: GBT440']}], 'interventions': [{'name': 'GBT440', 'type': 'DRUG', 'description': 'Test: GBT440 300 mg capsule (high-strength) Reference: GBT440 100 mg capsule (low-strength)', 'armGroupLabels': ['Treatment Sequence 1', 'Treatment Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON Early Phase Services, LLC Clinical Research Unit', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Carla Washington, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Global Blood Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Global Blood Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}