Study of GBT021601 in Participants With Renal Impairment

Renal Impairment Clinical Trial

Official title:

A Phase I, Open-Label, Single-Dose, Non-Randomized, Parallel Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Adult Participants With Renal Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05878704
• Other study ID #: GBT021601-014
• Secondary ID: C5351007
• Status: Recruiting
• Phase: Phase 1
• Start date: June 29, 2023
• Est. completion date: October 4, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Renal Impairment study of GBT021601.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 4, 2024
• Est. primary completion date: October 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• GBT021601
Oral

Locations

Country	Name	City	State
United States	Orange County Research Center	Lake Forest	California
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Nucleus Network	Saint Paul	Minnesota
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single-dose PK parameters for GBT021601 in RBC	To evaluate the single-dose RBC PK of GBT021601 in participants with RI	Up to 112 Days
Other	Amount of GBT021601 excreted in urine	To evaluate the urinary excretion of GBT021601 in participants with RI following a single dose	Up to 112 Days
Other	Descriptive analysis of eGFR versus PK exposure parameters	The relationship of eGFR, as estimated using serum creatinine and serum cystatin C on GBT021601 PK exposure in participants with RI	Up to 112 Days
Other	Protein binding of GBT021601 in plasma	To evaluate the protein binding of GBT021601 in participants with RI	Up to 112 Days
Other	Single-dose PK parameters for GBT021601 in RBC	To evaluate the single-dose RBC PK of GBT021601 in participants with ESRD receiving IHD	Up to 112 Days
Other	Extraction ratio of GBT021601 via dialysis and concentration of GBT021601 in dialysate	To evaluate the clearance of GBT021601 by IHD in participants with ESRD	Up to 112 Days
Primary	Concentration of GBT021601 in whole blood and plasma	To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment (RI)	Up to 112 Days
Primary	Single-dose PK parameters	To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment	Up to 112 Days
Secondary	Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs	To evaluate the safety and tolerability of single dose GBT021601 in participants with renal impairment	Up to 112 Days
Secondary	Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs	To evaluate the safety and tolerability of GBT021601 in ESRD participants receiving IHD following a single dose	Up to 112 Days

External Links

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