Study of GBT021601 in Participants With Renal Impairment

Stopped early · Phase 1

Conditions studied: Renal Impairment

In brief

Renal Impairment study of GBT021601.

Key facts

Study ID

NCT05878704

Run by

Pfizer

People needed

8

Starts

2023-06-29

Expected to finish

2024-07-29

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Orange County Research Center — Lake Forest, California, United States
• Orange County Research Center — Tustin, California, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Nucleus Network — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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