A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-30

Study Completion Date

2018-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tucatinib

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

Single dose of 300 mg of \[¹⁴C\]-tucatinib containing approximately 150 μCi of \[¹⁴C\] radioactivity

Interventions

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tucatinib

Single dose of 300 mg of \[¹⁴C\]-tucatinib containing approximately 150 μCi of \[¹⁴C\] radioactivity

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes