A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/1/2018 |
| Start Date: | December 30, 2017 |
| End Date: | January 30, 2018 |
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [¹⁴C]-Tucatinib Following a Single Oral Dose in Healthy Male and Female Subjects
This study will look at how a drug (tucatinib) leaves the body and what happens to tucatinib
while it is still in the body. Healthy participants will get one dose of tucatinib by mouth.
Patients will be monitored for 8-14 days after they take the dose of tucatinib.
while it is still in the body. Healthy participants will get one dose of tucatinib by mouth.
Patients will be monitored for 8-14 days after they take the dose of tucatinib.
This study will examine the absorption, metabolism, and excretion of tucatinib in healthy
individuals. Participants will receive one oral dose of tucatinib and will be followed for
8-14 days after the dose is received.
individuals. Participants will receive one oral dose of tucatinib and will be followed for
8-14 days after the dose is received.
Inclusion Criteria:
- In good health, determined by no clinically significant findings from medical history,
physical examination, 12-lead ECG, vital signs measurements, or lab evaluations
- Body mass index (BMI) between 18 and 32 kg/m²
- Weight between 50 and 100 kg
- Females must be of non-childbearing potential
- Males must agree to use contraception
Exclusion Criteria:
- History of any metabolic, allergic, dermatological, hepatic, renal, hematological,
pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or
psychiatric disorder
- Any condition affecting drug absorption
- History of hypersensitivity or allergy to any drug compound, food, or other substance
- History of alcoholism or drug/chemical abuse within 2 years
- Use of prescription products within 28 days prior to check in
- Use of tobacco- or nicotine-containing products within 3 months prior to check in
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