A Safety, Tolerability, and Pharmacokinetic Study of Tucatinib in Healthy Japanese and Caucasian Subjects

NCT ID: NCT03914755

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-08
• Study Completion Date: 2019-08-04

Brief Summary

This study is being done to compare the pharmacokinetics (PK) and safety/tolerability of tucatinib in healthy Japanese and Caucasian participants.

Three cohorts of healthy Japanese and Caucasian men and women will be admitted to the Clinical Research Unit (CRU) and receive multiple oral doses of tucatinib over 14 days with and without food.

Subjects will be in the study for up to 45 days, including the screening period.

Due to practical considerations, each cohort will be dosed sequentially (this is not a dose escalation study).

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

50 mg twice daily on Days 1-13 and once daily on Day 14

Group Type: EXPERIMENTAL

Tucatinib

Intervention Type: DRUG

Administered via oral tablet

Cohort 2

150 mg twice daily on Days 1-13 and once daily on Day 14

Group Type: EXPERIMENTAL

Tucatinib

Intervention Type: DRUG

Administered via oral tablet

Cohort 3

300 mg twice daily on Days 1-13 and once daily on Day 14

Group Type: EXPERIMENTAL

Tucatinib

Intervention Type: DRUG

Administered via oral tablet

Interventions

Tucatinib

Administered via oral tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index between 18 and 32 kg/m^2 and a total body weight between 50 and 100 kg
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiograms, vital signs measurements, or clinical laboratory evaluations
• Female subjects participating in the study will be of non-childbearing potential. Male subjects will be surgically sterile for at least 90 days or will agree to use contraception during the study and for 90 days after last dose of study drug.
• Japanese subjects:

1. Must have been born in Japan

2. Must have 2 biological Japanese parents and 4 biological Japanese grandparents as confirmed by interview

3. Must have spent less than 10 years outside of Japan, and has no significant changes in lifestyle, including diet, since leaving Japan

Exclusion Criteria

• Significant history of metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
• Current condition possibly affecting drug absorption
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
• History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs
• History of alcoholism or drug/chemical abuse within 2 years of check-in
• History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects
• Positive hepatitis panel and/or positive human immunodeficiency (HIV) test
• Liver function tests, serum creatinine, hemoglobin, or hematocrit values outside of the normal reference range
• Single 12-lead ECG demonstrating QTcF>450 msec for males or >470 msec for females
• Participation in a clinical study involving administration of an investigational drug in the past 30 days from last dose or 5 half-lives (whichever is longer)
• Use of any products known to alter drug absorption, metabolism or elimination processes, including St. John's wort and known strong inhibitors or inducers of CYP3A4 or CYP2C8, within 30 days
• Use of or intention to use any prescription or nonprescription products, including vitamins, minerals and herbal preparations within 14 days
• Use of tobacco- or nicotine-containing products within 3 months
• Receipt of blood products within 2 months
• Donation of blood from 56 days before the Screening Visit, plasma from 2 weeks before the Screening Visit or platelets from 6 weeks before the Screening Visit
• Poor peripheral venous access
• Have previously completed or withdrawn from this study or any other study investigating tucatinib and have previously received the study drug

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seagen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Woolery, PharmD, BCOP

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

PAREXEL International, Early Phase Clinical Unit - Los Angeles

Glendale, California, United States

Countries

United States

References

Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5.

Reference Type: DERIVED

PMID: 39368039 (View on PubMed)

Other Identifiers

SGNTUC-015

Identifier Type: -

Identifier Source: org_study_id