Study of GBT021601 in Participants With Renal Impairment

Phase 1

Terminated

• Conditions: Renal Impairment
• Interventions: Drug: GBT021601

• Registration Number: NCT05878704
• Lead Sponsor: Pfizer

Brief Summary

Renal Impairment study of GBT021601.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-26
• Study Start: 2023-06-29
• Primary Completion: 2024-07-29
• Study Completion: 2024-07-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	GBT021601	GBT021601

Primary Outcome Measures

Name	Time	Method
Concentration of GBT021601 in whole blood and plasma	Up to 112 Days	To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment (RI)
Single-dose PK parameters	Up to 112 Days	To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs	Up to 112 Days	To evaluate the safety and tolerability of GBT021601 in ESRD participants receiving IHD following a single dose

Trial Locations

Locations (3)

Orange County Research Center; 🇺🇸 Tustin, California, United States

Advanced Pharma CR, LLC; 🇺🇸 Miami, Florida, United States

Nucleus Network; 🇺🇸 Saint Paul, Minnesota, United States