NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Study of GBT021601 in Participants With Renal Impairment

NCT05878704

TerminatedPhase 1

Sponsor: Pfizer

Conditions: Renal Impairment

Interventions: GBT021601

Countries: United States

Renal Impairment study of GBT021601.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (4)

Lake Forest, California, United States
Tustin, California, United States
Miami, Florida, United States
Saint Paul, Minnesota, United States