Back to resultsStudy of GBT021601 in Participants With Renal Impairment
Primary Purpose
Renal Impairment
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GBT021601
Sponsored by
About this trial
This is an interventional treatment trial for Renal Impairment focused on measuring End stage renal disease, Sickle Cell Disease
Eligibility 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.
Sites / Locations
- Orange County Research CenterRecruiting
- Advanced Pharma CR, LLCRecruiting
- Nucleus NetworkRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
GBT021601
Outcomes
Primary Outcome Measures
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)
Single-dose PK parameters
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
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
To evaluate the safety and tolerability of GBT021601 in ESRD participants receiving IHD following a single dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05878704
Brief Title
Study of GBT021601 in Participants With Renal Impairment
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
July 9, 2024 (Anticipated)
Study Completion Date
July 9, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
End stage renal disease, Sickle Cell Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
GBT021601
Intervention Type
Drug
Intervention Name(s)
GBT021601
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Concentration of GBT021601 in whole blood and plasma
Description
To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment (RI)
Time Frame
Up to 112 Days
Title
Single-dose PK parameters
Description
To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment
Time Frame
Up to 112 Days
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs
Description
To evaluate the safety and tolerability of single dose GBT021601 in participants with renal impairment
Time Frame
Up to 112 Days
Title
Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs
Description
To evaluate the safety and tolerability of GBT021601 in ESRD participants receiving IHD following a single dose
Time Frame
Up to 112 Days
Other Pre-specified Outcome Measures:
Title
Single-dose PK parameters for GBT021601 in RBC
Description
To evaluate the single-dose RBC PK of GBT021601 in participants with RI
Time Frame
Up to 112 Days
Title
Amount of GBT021601 excreted in urine
Description
To evaluate the urinary excretion of GBT021601 in participants with RI following a single dose
Time Frame
Up to 112 Days
Title
Descriptive analysis of eGFR versus PK exposure parameters
Description
The relationship of eGFR, as estimated using serum creatinine and serum cystatin C on GBT021601 PK exposure in participants with RI
Time Frame
Up to 112 Days
Title
Protein binding of GBT021601 in plasma
Description
To evaluate the protein binding of GBT021601 in participants with RI
Time Frame
Up to 112 Days
Title
Single-dose PK parameters for GBT021601 in RBC
Description
To evaluate the single-dose RBC PK of GBT021601 in participants with ESRD receiving IHD
Time Frame
Up to 112 Days
Title
Extraction ratio of GBT021601 via dialysis and concentration of GBT021601 in dialysate
Description
To evaluate the clearance of GBT021601 by IHD in participants with ESRD
Time Frame
Up to 112 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Individual Site Status
Recruiting
Facility Name
Nucleus Network
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=GBT021601-014
Description
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Learn more about this trial
Study of GBT021601 in Participants With Renal Impairment
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