HealthyPhase 1NCT03914755
A Safety, Tolerability, and Pharmacokinetic Study of Tucatinib in Healthy Japanese and Caucasian Subjects
A Phase 1 study testing Tucatinib in people with Healthy, run by Seagen Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tucatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2019to 4 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- Must have been born in Japan
- Must have 2 biological Japanese parents and 4 biological Japanese grandparents as confirmed by interview
- Must have spent less than 10 years outside of Japan, and has no significant changes in lifestyle, including diet, since leaving Japan
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
PAREXEL International, Early Phase Clinical Unit - Los Angeles
Glendale, California, 91206
About this study
Official title: A Phase 1, Open Label, Safety, Tolerability, and Pharmacokinetic Study of Tucatinib (ONT-380) in Healthy Japanese and Caucasian Subjects
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
- Being tested
- Tucatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucatinibDrug
Administered via oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 50 mg twice daily on Days 1-13 and once daily on Day 14 Receives: Drug: Tucatinib |
| Cohort 2 | Experimental | 150 mg twice daily on Days 1-13 and once daily on Day 14 Receives: Drug: Tucatinib |
| Cohort 3 | Experimental | 300 mg twice daily on Days 1-13 and once daily on Day 14 Receives: Drug: Tucatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of tucatinib
Measured: 14 days
Cmax of ONT-993
Measured: 14 days
Time of the maximum observed concentration (tmax) of tucatinib
Measured: 14 days
Tmax of ONT-993
Measured: 14 days
AUC from time 0 to the time of last quantifiable concentration (AUClast) of tucatinib
Measured: 14 days
AUClast of ONT-993
Measured: 14 days
AUC from time 0 to 12 hours postdose (AUC0-12hr) of tucatinib
Measured: 14 days
AUC0-12hr of ONT-993
Measured: 14 days
AUC from time 0 extrapolated to infinity (AUC0-inf) of tucatinib
Measured: 1 day
AUC from time 0 extrapolated to infinity (AUC0-inf) of ONT-993
Measured: 1 day
Percentage of AUC0-inf due to extrapolation (%AUCextrap) of tucatinib
Measured: 1 day
%AUCextrap of ONT-993
Measured: 1 day
Apparent total clearance (CL/F) of tucatinib
Measured: 14 days
Apparent volume of distribution during the terminal phase (Vz/F) of tucatinib
Measured: 14 days
Metabolite-to-parent molar ratio based on AUC (MRAUC) of ONT-993
Measured: 14 days
Secondary outcomes (1)
Incidence of adverse events (AEs)
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start8 May 2019
- Primary completion4 Aug 2019
- Study completion4 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Woolery, PharmD, BCOP, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914755
- Sponsor's protocol ID
- SGNTUC-015
- Status last verified
- Sep 2019
- First submitted
- 10 Apr 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39368039
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Safety, Tolerability, and Pharmacokinetic Study of Tucatinib (ONT-380) in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT03914755
- Acronym / sponsor ID
- SGNTUC-015
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- 8 May 2019 (actual)
- Primary completion
- 4 Aug 2019 (actual)
- Study completion
- 4 Aug 2019 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Tucatinib50 mg twice daily on Days 1-13 and once daily on Day 14 |
| Cohort 2 | Experimental | Drug: Tucatinib150 mg twice daily on Days 1-13 and once daily on Day 14 |
| Cohort 3 | Experimental | Drug: Tucatinib300 mg twice daily on Days 1-13 and once daily on Day 14 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TucatinibAdministered via oral tablet | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Maximum observed concentration (Cmax) of tucatinib
Time frame: 14 days
Cmax of ONT-993
Time frame: 14 days
Time of the maximum observed concentration (tmax) of tucatinib
Time frame: 14 days
Tmax of ONT-993
Time frame: 14 days
AUC from time 0 to the time of last quantifiable concentration (AUClast) of tucatinib
Time frame: 14 days
AUClast of ONT-993
Time frame: 14 days
AUC from time 0 to 12 hours postdose (AUC0-12hr) of tucatinib
Time frame: 14 days
AUC0-12hr of ONT-993
Time frame: 14 days
AUC from time 0 extrapolated to infinity (AUC0-inf) of tucatinib
Time frame: 1 day
AUC from time 0 extrapolated to infinity (AUC0-inf) of ONT-993
Time frame: 1 day
Percentage of AUC0-inf due to extrapolation (%AUCextrap) of tucatinib
Time frame: 1 day
%AUCextrap of ONT-993
Time frame: 1 day
Apparent total clearance (CL/F) of tucatinib
Time frame: 14 days
Apparent volume of distribution during the terminal phase (Vz/F) of tucatinib
Time frame: 14 days
Metabolite-to-parent molar ratio based on AUC (MRAUC) of ONT-993
Time frame: 14 days
1 secondary outcome
Incidence of adverse events (AEs)
Time frame: 17 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 39368039Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Woolery, PharmD, BCOP study director
Seagen Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tucatinib in people with Healthy, run by Seagen Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) of tucatinib (time frame: 14 days). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03914755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.