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Active Not Recruiting
NCT05718687
A GBT021601 ADME Microtracer Study in Healthy Volunteers
Conditions: Sickle Cell Disease
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 10
Sponsor: Global Blood Therapeutics
Location: Netherlands
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.
Eligibility Criteria
Inclusion Criteria:Body mass index (BMI): 18.0 to 27.0 kg/m2, inclusive, at screening.Body weight ≥ 50 kg at screeningFemales 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 defecationSignificant 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.
Source: ClinicalTrials.gov (NCT05718687). StuddyBuddy aggregates publicly available trial information.