A GBT021601 ADME Microtracer Study in Healthy Volunteers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2023-08-10

Brief Summary

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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.

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Detailed Description

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This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment

open-label GBT021601

Group Type EXPERIMENTAL

GBT021601

Intervention Type DRUG

Single oral dose of 200 mg GBT021601, containing \~74 kBq (\~2 µCi) of \[14C\]-GBT021601

Interventions

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GBT021601

Single oral dose of 200 mg GBT021601, containing \~74 kBq (\~2 µCi) of \[14C\]-GBT021601

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes