Study of GBT021601 in Participants With Renal Impairment
- Registration Number
- NCT05878704
- Lead Sponsor
- Pfizer
- Brief Summary
Renal Impairment study of GBT021601.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Males or females, ≥ 18 years of age at the time of Screening.
- 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).
- Has a stable renal function with no clinically significant change in renal status at least 1 month prior to study drug administration.
Exclusion Criteria
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment GBT021601 GBT021601
- Primary Outcome Measures
Name Time Method Concentration of GBT021601 in whole blood and plasma Up to 112 Days To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment (RI)
Single-dose PK parameters Up to 112 Days To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment
- Secondary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs Up to 112 Days To evaluate the safety and tolerability of GBT021601 in ESRD participants receiving IHD following a single dose
Trial Locations
- Locations (3)
Orange County Research Center
🇺🇸Tustin, California, United States
Advanced Pharma CR, LLC
🇺🇸Miami, Florida, United States
Nucleus Network
🇺🇸Saint Paul, Minnesota, United States