A GBT021601 ADME Microtracer Study in Healthy Volunteers

Pfizer

Status and phase

Completed

Phase 1

Conditions

Sickle Cell Disease

Treatments

Drug: GBT021601

Study type

Interventional

Funder types

Industry

Identifiers

NCT05718687

C5351003 (Other Identifier)

2022-003108-34 (EudraCT Number)

GBT021601-013

Details and patient eligibility

About

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.

Full description

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

Enrollment

9 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts 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.