Study of GBT021601 in Participants With Renal Impairment
Study Details
Study Description
Brief Summary
Renal Impairment study of GBT021601.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment GBT021601 |
Drug: GBT021601
Oral
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 single dose GBT021601 in participants with renal impairment
- 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
Other Outcome Measures
- Single-dose PK parameters for GBT021601 in RBC [Up to 112 Days]
To evaluate the single-dose RBC PK of GBT021601 in participants with RI
- Amount of GBT021601 excreted in urine [Up to 112 Days]
To evaluate the urinary excretion of GBT021601 in participants with RI following a single dose
- Descriptive analysis of eGFR versus PK exposure parameters [Up to 112 Days]
The relationship of eGFR, as estimated using serum creatinine and serum cystatin C on GBT021601 PK exposure in participants with RI
- Protein binding of GBT021601 in plasma [Up to 112 Days]
To evaluate the protein binding of GBT021601 in participants with RI
- Single-dose PK parameters for GBT021601 in RBC [Up to 112 Days]
To evaluate the single-dose RBC PK of GBT021601 in participants with ESRD receiving IHD
- Extraction ratio of GBT021601 via dialysis and concentration of GBT021601 in dialysate [Up to 112 Days]
To evaluate the clearance of GBT021601 by IHD in participants with ESRD
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Global Blood Therapeutics
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GBT021601-014
- C5351007