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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914755
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

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).


Condition or disease Intervention/treatment Phase
Healthy Drug: Tucatinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Safety, Tolerability, and Pharmacokinetic Study of Tucatinib (ONT-380) in Healthy Japanese and Caucasian Subjects
Actual Study Start Date : May 8, 2019
Actual Primary Completion Date : August 4, 2019
Actual Study Completion Date : August 4, 2019

Arm Intervention/treatment
Experimental: Cohort 1
50 mg twice daily on Days 1-13 and once daily on Day 14
Drug: Tucatinib
Administered via oral tablet

Experimental: Cohort 2
150 mg twice daily on Days 1-13 and once daily on Day 14
Drug: Tucatinib
Administered via oral tablet

Experimental: Cohort 3
300 mg twice daily on Days 1-13 and once daily on Day 14
Drug: Tucatinib
Administered via oral tablet




Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) of tucatinib [ Time Frame: 14 days ]
  2. Cmax of ONT-993 [ Time Frame: 14 days ]
  3. Time of the maximum observed concentration (tmax) of tucatinib [ Time Frame: 14 days ]
  4. Tmax of ONT-993 [ Time Frame: 14 days ]
  5. AUC from time 0 to the time of last quantifiable concentration (AUClast) of tucatinib [ Time Frame: 14 days ]
  6. AUClast of ONT-993 [ Time Frame: 14 days ]
  7. AUC from time 0 to 12 hours postdose (AUC0-12hr) of tucatinib [ Time Frame: 14 days ]
  8. AUC0-12hr of ONT-993 [ Time Frame: 14 days ]
  9. AUC from time 0 extrapolated to infinity (AUC0-inf) of tucatinib [ Time Frame: 1 day ]
  10. AUC from time 0 extrapolated to infinity (AUC0-inf) of ONT-993 [ Time Frame: 1 day ]
  11. Percentage of AUC0-inf due to extrapolation (%AUCextrap) of tucatinib [ Time Frame: 1 day ]
  12. %AUCextrap of ONT-993 [ Time Frame: 1 day ]
  13. Apparent total clearance (CL/F) of tucatinib [ Time Frame: 14 days ]
  14. Apparent volume of distribution during the terminal phase (Vz/F) of tucatinib [ Time Frame: 14 days ]
  15. Metabolite-to-parent molar ratio based on AUC (MRAUC) of ONT-993 [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: 17 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914755


Locations
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United States, California
PAREXEL International, Early Phase Clinical Unit - Los Angeles
Glendale, California, United States, 91206
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Joseph Woolery, PharmD, BCOP Seattle Genetics, Inc.
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03914755    
Other Study ID Numbers: SGNTUC-015
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No