A GBT021601 ADME Microtracer Study in Healthy Volunteers
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment open-label GBT021601 |
Drug: GBT021601
Single oral dose of 200 mg GBT021601, containing ~74 kBq (~2 µCi) of [14C]-GBT021601
|
Outcome Measures
Primary Outcome Measures
- To determine the whole blood and plasma concentrations of 14C-GBT021601 total radioactivity. [Day 1 to Day 206, maximum]
Total radioactivity pharmacokinetics concentration over time profiles.
- To assess the mass balance by determining 14C-GBT021601 total radioactivity excreted in urine and feces. [Day 1 to Day 206, maximum]
Excretion of total radioactivity in urine and feces.
- To determine the pharmacokinetics of GBT021601 in whole blood, plasma, and urine. [Day 1 to Day 206, maximum]
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. [Baseline to Day 206, maximum]
Number of participants with adverse events
- To characterize and identify metabolites of 14C-GBT021601 in whole blood, plasma, urine, and feces. [Day 1 to Day 206, maximum]
Identification of metabolites in whole blood, plasma, urine, and feces.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ICON Clinical Research Unit | Groningen | Netherlands |
Sponsors and Collaborators
- Global Blood Therapeutics
Investigators
- Study Director: Adeyemi Adenola, MD, MPH, Global Blood Therapeutics, a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GBT021601-013