A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| End Date: | February 2016 |
| Contact: | Lawrene N. Tardo |
| Phone: | 210-238-4552 |
A Phase 1, Single-Dose, Open-Label, Randomized, Two-Period Crossover Study to Evaluate the Relative Bioavailability of GBT440 300 mg Administered as Capsule Formulations in Healthy Subjects
The purpose of this study is to evaluate the relative bioavailability of a single 300 mg
dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3
× 100 mg) capsule formulation in healthy fasted subjects.
dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3
× 100 mg) capsule formulation in healthy fasted subjects.
Inclusion Criteria:
- Subject is a female of non-childbearing potential or male, who is healthy,
nonsmoking, and 18 to 60 years old, inclusive, at screening
- Male subjects agree to use contraception
- Willing and able to give written informed consent
Exclusion Criteria:
- Evidence or history of clinically significant metabolic, allergic, dermatological,
hepatic, renal,hematological, pulmonary, cardiovascular, gastrointestinal,
neurological, or psychiatric disorder
- History of hypersensitivity or allergy to drugs, foods, or other substances
- History or presence of abnormal electrocardiogram or hypertension
- History of alcohol abuse, illicit drug use, significant mental illness, physical
dependence to any opioid, or any history of drug abuse or addiction within 1 year of
screening
- Participated in another clinical trial of an investigational drug within 30 days (or
5 half-lives of the investigational drug, whichever is longer) prior to Screening
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