Study of GBT021601 in Participants With Renal Impairment
Reason given: 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.
Key facts
- Where
- Lake Forest, Miami, Saint Paul, and Tustin, United StatesSee the 4 sites
- Phase
- Phase 1
Where in United States
- Orange County Research CenterLake Forest, United StatesNo longer taking part
- Advanced Pharma CR, LLCMiami, United StatesNo longer taking part
- Nucleus NetworkSaint Paul, United StatesNo longer taking part
- Orange County Research CenterTustin, United StatesNo longer taking part
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT05878704
- Record updated
- 15 October 2024
- Original description
Renal Impairment study of GBT021601.Read full original descriptionShow less
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
Renal Impairment study of GBT021601.
Inclusion: 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: 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; 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.