sickle cell anemia sickle cell disease
Conditions
Interventions
The volunteer will be given 200 milligrams (mg) 14C labeled GBT021601 as an
oral solution of 400 milliliters (mL). This oral solution may have a bitter
taste. After administration of the oral soluti
Sponsors
Global Blood Therapeutics, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Sex: Male or female. 2. Age: 18 to 55 years, inclusive, at screening. 3. Body mass index (BMI): 18.0 to 27.0 kg/m2, inclusive, at screening. 4. Body weight: >=50 kg at screening. 5. Good physical and mental health on the basis of medical and surgical history, physical examination, clinical laboratory (including clinical chemistry, hematology, urinalysis, and coagulation), 12 lead electrocardiogram (ECG), and vital signs, as judged by the Investigator. Further criteria apply
Exclusion criteria
Exclusion criteria: 1. Employee of ICON or the Sponsor. 2. History or presence of clinically significant allergic diseases (except for untreated, asymptomatic, seasonal allergies at time of dosing), in the opinion of the Investigator. 3. 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. 4. History of chronic constipation, or recent complaints of an irregular defecation pattern (ie, less than once per day on average) in the opinion of the Investigator. 5. History of surgery requiring general anesthesia (not including local procedures) or major trauma within 12 weeks of screening, or a planned surgery during participation in the study. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To determine the whole blood and plasma concentrations of [14C]-GBT021601 total radioactivity. - To assess the mass balance by determining [14C]-GBT021601 total radioactivity excreted in urine and feces. - To determine the PK of GBT021601 in whole blood, plasma, and urine. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the safety and tolerability of GBT021601 administration in healthy participants. - To characterize and identify metabolites of [14C]-GBT021601 in whole blood, plasma, urine, and feces. | — |
Countries
Netherlands
Outcome results
None listed