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A GBT021601 ADME Microtracer Study in Healthy Volunteers

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
GBT021601
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sickle Cell Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Body mass index (BMI): 18.0 to 27.0 kg/m2, inclusive, at screening. Body weight ≥ 50 kg at screening Females must be nonlactating and nonpregnant (as confirmed by a negative serum pregnancy test at screening and admission for all females), or of nonchildbearing potential (ie, either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [defined as at least 12 months no menses, and confirmed by a follicle-stimulating hormone test, at screening]). Creatinine clearance (glomerular filtration rate) as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula: ≥90 mL/min, at screening. Exclusion Criteria: History or presence of conditions which, in the opinion of the Investigator, are known to interfere with the ADME of drugs, such as previous surgery on the gastrointestinal tract (including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas). Participants who have a history of appendectomy are eligible for enrollment. History of chronic constipation, or recent complaints of an irregular defecation Significant and/or acute illness at screening or within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator. Known personal or family history of congenital long QT syndrome or known family history of sudden death. Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year prior to screening.

Sites / Locations

  • ICON Early Phase Clinic, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

open-label GBT021601

Outcomes

Primary Outcome Measures

To determine the whole blood and plasma concentrations of 14C-GBT021601 total radioactivity.
Total radioactivity pharmacokinetics concentration over time profiles.
To assess the mass balance by determining 14C-GBT021601 total radioactivity excreted in urine and feces.
Excretion of total radioactivity in urine and feces.
To determine the pharmacokinetics of GBT021601 in whole blood, plasma, and urine.
GBT021601 pharmacokinetics concentration over time profiles in whole blood and plasma. Amount of GBT021601 excreted in urine.

Secondary Outcome Measures

To assess the safety and tolerability of GBT021601 administration in healthy participants.
Number of participants with adverse events
To characterize and identify metabolites of 14C-GBT021601 in whole blood, plasma, urine, and feces.
Identification of metabolites in whole blood, plasma, urine, and feces.

Full Information

First Posted
January 30, 2023
Last Updated
September 18, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05718687
Brief Title
A GBT021601 ADME Microtracer Study in Healthy Volunteers
Official Title
A PHASE 1 STUDY TO ASSESS THE MASS BALANCE, EXCRETION, AND PHARMACOKINETICS OF [14C]-GBT021601, AN ORAL HEMOGLOBIN SPOLYMERIZATION INHIBITOR, IN HEALTHY PARTICIPANTS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
August 11, 2023 (Actual)
Study Completion Date
August 11, 2023 (Actual)

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
An Open-label Study of GBT021601 in 8 to 10 healthy male or female participants to evaluate the absorption, distribution, metabolism, and excretion (ADME) of GBT021601.
Detailed Description
This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
open-label GBT021601
Intervention Type
Drug
Intervention Name(s)
GBT021601
Intervention Description
Single oral dose of 200 mg GBT021601, containing ~74 kBq (~2 µCi) of [14C]-GBT021601
Primary Outcome Measure Information:
Title
To determine the whole blood and plasma concentrations of 14C-GBT021601 total radioactivity.
Description
Total radioactivity pharmacokinetics concentration over time profiles.
Time Frame
Day 1 to Day 206, maximum
Title
To assess the mass balance by determining 14C-GBT021601 total radioactivity excreted in urine and feces.
Description
Excretion of total radioactivity in urine and feces.
Time Frame
Day 1 to Day 206, maximum
Title
To determine the pharmacokinetics of GBT021601 in whole blood, plasma, and urine.
Description
GBT021601 pharmacokinetics concentration over time profiles in whole blood and plasma. Amount of GBT021601 excreted in urine.
Time Frame
Day 1 to Day 206, maximum
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of GBT021601 administration in healthy participants.
Description
Number of participants with adverse events
Time Frame
Baseline to Day 206, maximum
Title
To characterize and identify metabolites of 14C-GBT021601 in whole blood, plasma, urine, and feces.
Description
Identification of metabolites in whole blood, plasma, urine, and feces.
Time Frame
Day 1 to Day 206, maximum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI): 18.0 to 27.0 kg/m2, inclusive, at screening. Body weight ≥ 50 kg at screening Females must be nonlactating and nonpregnant (as confirmed by a negative serum pregnancy test at screening and admission for all females), or of nonchildbearing potential (ie, either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [defined as at least 12 months no menses, and confirmed by a follicle-stimulating hormone test, at screening]). Creatinine clearance (glomerular filtration rate) as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula: ≥90 mL/min, at screening. Exclusion Criteria: History or presence of conditions which, in the opinion of the Investigator, are known to interfere with the ADME of drugs, such as previous surgery on the gastrointestinal tract (including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas). Participants who have a history of appendectomy are eligible for enrollment. History of chronic constipation, or recent complaints of an irregular defecation Significant and/or acute illness at screening or within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator. Known personal or family history of congenital long QT syndrome or known family history of sudden death. Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
ICON Early Phase Clinic, LLC
City
Groningen
ZIP/Postal Code
9728
Country
Netherlands

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=GBT021601-013
Description
To obtain contact information for a study center near you, click here.

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A GBT021601 ADME Microtracer Study in Healthy Volunteers

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