Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| End Date: | February 2016 |
A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of GBT440 on the Pharmacokinetics of Probe Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4 in Healthy Subjects
The purpose of this study to evaluate the effect of concomitant administration of GBT440 on
caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a
CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.
caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a
CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.
Inclusion Criteria:
- Subject is a female of non-childbearing potential or male, who is healthy,
nonsmoking, and 18 to 55 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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