A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | February 2016 |
A Phase 1 Study to Investigate Absorption, Metabolism, and Excretion After Establishment of Steady State Via GBT440 Loading and Maintenance Dosing Followed by a Single Oral Dose Administration of [14C]-GBT440 in Healthy Male Subjects
This study will provide information regarding the metabolic pathway of GBT440, the need for
evaluation of potential drug-drug interactions, and the need for studies in special
populations. The administration of radiolabeled drug is necessary to fully characterize the
rates and routes of elimination of GBT440, providing further quantitative information on the
disposition of GBT440. The results from this study will permit a comprehensive comparison
between animal and human routes of elimination and metabolic profiles of GBT440.
evaluation of potential drug-drug interactions, and the need for studies in special
populations. The administration of radiolabeled drug is necessary to fully characterize the
rates and routes of elimination of GBT440, providing further quantitative information on the
disposition of GBT440. The results from this study will permit a comprehensive comparison
between animal and human routes of elimination and metabolic profiles of GBT440.
Inclusion Criteria:
1. Healthy; non-smoking male; 18 to 55 years old, inclusive
2. Weighs at least 50 kg and not more than 110 kg
3. Agrees to use contraception
4. Willing and able to give written informed consent
Exclusion Criteria:
1. Evidence or history of clinically significant metabolic, allergic, dermatological,
hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal,
neurological, or psychiatric disorder
2. History of stomach or intestinal surgery that would potentially alter drug absorption
3. History of hypersensitivity or allergy to drugs, foods, or other substances
4. History or presence of abnormal electrocardiogram
5. Exposure to significant radiation or participated in more than 1 other radiolabeled
study drug trial within 12 months of Screening
6. 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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