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Keep this study
Lead
Pfizer
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
