Study of GBT021601 in Participants With Renal Impairment (NCT05878704) | Clinical Trial Compass
TerminatedPhase 1
Study of GBT021601 in Participants With Renal Impairment
Stopped: 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.
United States8 participantsStarted 2023-06-29
Plain-language summary
Renal Impairment study of GBT021601.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Concentration of GBT021601 in whole blood and plasma