Study of GBT021601 in Participants With Renal Impairment

Pfizer

Status and phase

Terminated

Phase 1

Conditions

Renal Impairment

Treatments

Drug: GBT021601

Study type

Interventional

Funder types

Industry

Identifiers

NCT05878704

C5351007 (Other Identifier)

GBT021601-014

Details and patient eligibility

About

Renal Impairment study of GBT021601.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.