Renal Impairment
Conditions
Keywords
End stage renal disease, Sickle Cell Disease
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.
Interventions
DRUGGBT021601
Oral
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 RI |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed