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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
Description
Renal Impairment study of GBT021601.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.
Trial Eligibility
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 Info
Organization
Pfizer
Primary Outcome
Concentration of GBT021601 in whole blood and plasma
Interventions
Locations Recruiting
Orange County Research Center
United States, California, Lake Forest
Orange County Research Center
United States, California, Tustin
Advanced Pharma CR, LLC
United States, Florida, Miami
Nucleus Network
United States, Minnesota, Saint Paul
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