Clinical trial NCT03758339: A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf])
timeFrame: Up to 14 days
measure: AUC from time 0 to last quantifiable concentration
timeFrame: Up to 14 days
measure: Maximum observed concentration
timeFrame: Up to 14 days
measure: Time of maximum observed concentration
timeFrame: Up to 14 days
measure: Apparent terminal elimination half-life
timeFrame: Up to 14 days
measure: Apparent total clearance
timeFrame: Up to 14 days
measure: Apparent volume of distribution
timeFrame: Up to 14 days
measure: AUC[0-inf] plasma tucatinib/total radioactivity ratio
timeFrame: Up to 14 days
measure: AUC[0-inf] blood/plasma ratio
timeFrame: Up to 14 days
measure: Amount excreted in urine (Aeu)
timeFrame: Up to 14 days
measure: Cumulative Aeu
timeFrame: Up to 14 days
measure: Percentage excreted in urine (Feu)
timeFrame: Up to 14 days
measure: Cumulative Feu
timeFrame: Up 14 days
measure: Renal clearance
timeFrame: Up to 14 days
measure: Amount excreted in feces [Aef]
timeFrame: Up to 14 days
measure: Cumulative Aef
timeFrame: Up to 14 days
measure: Percentage excreted in feces [Fef]
timeFrame: Up to 14 days
measure: Cumulative Fef
timeFrame: Up to 14 days
Secondary outcomes:
measure: Relative abundance of tucatinib and its metabolites eliminated in urine and feces
timeFrame: Up to 14 days
measure: Relative abundance of tucatinib and its metabolites in plasma
timeFrame: Up to 14 days
measure: Incidence of adverse events (AEs)
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Cascadian Therapeutics Inc.
name: Alex Vo, PhD
role: STUDY_DIRECTOR
References: