Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT05878704
Status:
TERMINATED
Last Update Posted:
2024-10-15
First Post:
2023-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of GBT021601 in Participants With Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Business decision to terminate the trial after the completion of Part 1: Cohort 1 (severe renal impairment). The decision to terminate the trial was not due to any potential safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Single-dose PK parameters for GBT021601 in RBC', 'timeFrame': 'Up to 112 Days', 'description': 'To evaluate the single-dose RBC PK of GBT021601 in participants with RI'}, {'measure': 'Amount of GBT021601 excreted in urine', 'timeFrame': 'Up to 112 Days', 'description': 'To evaluate the urinary excretion of GBT021601 in participants with RI following a single dose'}, {'measure': 'Descriptive analysis of eGFR versus PK exposure parameters', 'timeFrame': 'Up to 112 Days', 'description': 'The relationship of eGFR, as estimated using serum creatinine and serum cystatin C on GBT021601 PK exposure in participants with RI'}, {'measure': 'Protein binding of GBT021601 in plasma', 'timeFrame': 'Up to 112 Days', 'description': 'To evaluate the protein binding of GBT021601 in participants with RI'}, {'measure': 'Single-dose PK parameters for GBT021601 in RBC', 'timeFrame': 'Up to 112 Days', 'description': 'To evaluate the single-dose RBC PK of GBT021601 in participants with ESRD receiving IHD'}, {'measure': 'Extraction ratio of GBT021601 via dialysis and concentration of GBT021601 in dialysate', 'timeFrame': 'Up to 112 Days', 'description': 'To evaluate the clearance of GBT021601 by IHD in participants with ESRD'}], 'primaryOutcomes': [{'measure': 'Concentration of GBT021601 in whole blood and plasma', 'timeFrame': 'Up to 112 Days', 'description': 'To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment (RI)'}, {'measure': 'Single-dose PK parameters', 'timeFrame': 'Up to 112 Days', 'description': 'To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment'}], 'secondaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs', 'timeFrame': 'Up to 112 Days', 'description': 'To evaluate the safety and tolerability of single dose GBT021601 in participants with renal impairment'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs', 'timeFrame': 'Up to 112 Days', 'description': 'To evaluate the safety and tolerability of GBT021601 in ESRD participants receiving IHD following a single dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['End stage renal disease', 'Sickle Cell Disease'], 'conditions': ['Renal Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=GBT021601-014', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Renal Impairment study of GBT021601.', 'detailedDescription': 'This is a Phase 1, two-part, non-randomized, open-label, parallel group study to evaluate the PK, safety, and tolerability of GBT021601 following a single dose administration in adult participants with RI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females, ≥ 18 years of age at the time of Screening.\n* Have liver (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], and total bilirubin \\[direct and indirect\\]) and renal function tests, Hb, and hematocrit values within normal limits or are not clinically significant at Screening and Day -1 (Cohort 2 only).\n* Has a stable renal function with no clinically significant change in renal status at least 1 month prior to study drug administration.\n\nExclusion Criteria:\n\n* Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests unrelated to their medical condition related to renal impairment, that might confound the results of the study or pose an additional risk in administering study drug to the participant.\n* Evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at the time of study drug administration), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease unrelated to renal impairment.'}, 'identificationModule': {'nctId': 'NCT05878704', 'briefTitle': 'Study of GBT021601 in Participants With Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase I, Open-Label, Single-Dose, Non-Randomized, Parallel Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Adult Participants With Renal Impairment', 'orgStudyIdInfo': {'id': 'GBT021601-014'}, 'secondaryIdInfos': [{'id': 'C5351007', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'GBT021601', 'interventionNames': ['Drug: GBT021601']}], 'interventions': [{'name': 'GBT021601', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92630', 'city': 'Lake Forest', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.64697, 'lon': -117.68922}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '33147', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Pharma CR, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Nucleus Network', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}