AzTrials
AzTrials

HealthyPhase 1NCT03777761

Effects of Tucatinib on Cardiac Repolarization in Healthy Participants

A Phase 1 study testing tucatinib and moxifloxacin in people with Healthy, run by Seagen Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is looking at how the study drug, tucatinib, affects the heart. Tucatinib is being studied as a possible treatment for breast cancer. This study will recruit healthy volunteers. There are 3 parts in the study. Each volunteer will be in all 3 parts. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
tucatinib and moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteUnited States
Study dates
6 Dec 2018to 11 Mar 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Good health, determined by medical history, physical examination, 12-lead ECG, vital signs measurements, or clinical laboratory evaluations
  • Body mass index (BMI) between 18 and 32 kg/m^2
  • Body weight between 50 and 100 kg
  • Female subjects must be of non-childbearing potential
  • Male subjects must agree to use contraception or be surgically sterile for at least 90 days

Who cannot join

  • Significant 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
  • Single 12-lead ECG demonstrating QTcF >450 msec for males or >470 msec for females, or history/evidence of long QT syndrome
  • History of alcoholism or drug/chemical abuse within 2 years
  • Use of prescription products within 30 days prior to check in
  • Use of nonprescription products within 14 days prior to check in, including vitamins, minerals, and herbal supplements
  • Use of tobacco- or nicotine-containing products within 3 months prior to check in

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Unit - Dallas

    Dallas, Texas, 75247

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Partially Double-Blind, Placebo- and Positive-controlled Study to Evaluate the Effect of Tucatinib on Cardiac Repolarization in Healthy Subjects

This study is looking at how the study drug, tucatinib, affects the heart. Tucatinib is being studied as a possible treatment for breast cancer. This study will recruit healthy volunteers. There are 3 parts in the study. Each volunteer will be in all 3 parts. One part will be to take the study drug, the second part will be to take a placebo (pill with no medicine), and the third part will be to take moxifloxacin. The volunteers will only know what part of the study they are in when they take moxifloxacin. For the study drug and placebo parts, volunteers will take 2 pills by mouth for 5 days. For the moxifloxacin part, volunteers will take 1 pill by mouth for 1 day.

Read the detailed description

This study will evaluate the effects of a steady state therapeutic dose of tucatinib on QTcF (QT interval corrected for heart rate using Fridericia's method) in healthy individuals. In this design, study treatment will be dosed in 3 sequential treatment periods:

Treatment A: Oral doses of 300mg tucatinib for 5 days

Treatment B: Oral doses of matching placebo for tucatinib for 5 days

Treatment C: A single oral dose of 400 mg of moxifloxacin

Patients will be randomized based on 2-Williams-square design to 1 of 6 treatment sequences to maintain the study blind for tucatinib and placebo.

Conditions
Healthy
Being tested
tucatinib, placebo, moxifloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tucatinibDrug

    300mg oral dose

  • placeboDrug

    Matching placebo for tucatinib

  • moxifloxacinDrug

    400mg single oral dose

Study groups in NCT03777761
Study groupRoleWhat they receive
Treatment Sequence ABCExperimentaltucatinib + placebo + moxifloxacin (administered in sequential treatment periods)
Receives: Drug: tucatinib; Drug: placebo; Drug: moxifloxacin
Treatment Sequence CABExperimentalmoxifloxacin + tucatinib + placebo (administered in sequential treatment periods)
Receives: Drug: tucatinib; Drug: placebo; Drug: moxifloxacin
Treatment Sequence BCAExperimentalplacebo + moxifloxacin + tucatinib (administered in sequential treatment periods)
Receives: Drug: tucatinib; Drug: placebo; Drug: moxifloxacin
Treatment Sequence CBAExperimentalmoxifloxacin + placebo + tucatinib (administered in sequential treatment periods)
Receives: Drug: tucatinib; Drug: placebo; Drug: moxifloxacin
Treatment Sequence ACBExperimentaltucatinib + moxifloxacin + placebo (administered in sequential treatment periods)
Receives: Drug: tucatinib; Drug: placebo; Drug: moxifloxacin
Treatment Sequence BACExperimentalplacebo + tucatinib + moxifloxacin (administered in sequential treatment periods)
Receives: Drug: tucatinib; Drug: placebo; Drug: moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Placebo-corrected change-from-baseline in QTcF

    QTcF is the QT interval corrected for heart rate using Fridericia's method.

    Measured: Up to 32 days

Secondary outcomes (24)

  1. Change from baseline in heart rate (HR)

    Measured: Up to 32 days

  2. Change from baseline in QTcF

    Measured: Up to 32 days

  3. Change from baseline in PR interval

    Measured: Up to 32 days

  4. Change from baseline in QRS interval

    Measured: Up to 32 days

  5. Placebo-corrected change from baseline in HR

    Measured: Up to 32 days

  6. Placebo-corrected change from baseline in PR interval

    Measured: Up to 32 days

  7. Placebo-corrected change from baseline in QRS interval

    Measured: Up to 32 days

  8. • Number of participants who experience increases in absolute QTcF interval values >450 msec

    Measured: Up to 32 days

  9. • Number of participants who experience QTcF interval changes from predose baseline of >30msec

    Measured: Up to 32 days

  10. • Number of participants who experience an increase in PR interval from predose baseline of >25% to a PR >200 msec

    Measured: Up to 32 days

  11. • Number of participants who experience an increase in QRS interval from predose baseline >25% to a QRS >120 msec

    Measured: Up to 32 days

  12. • Number of participants who experience a decrease in heart rate >25% from baseline to a heart rate <50

    Measured: Up to 32 days

  13. • Number of participants who experience an increase in heart rate >25% from baseline to a heart rate >100

    Measured: Up to 32 days

  14. Frequency of treatment-emergent changes of T-wave morphology and U-wave presence

    Measured: Up to 32 days

  15. Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUC[0-inf]) for tucatinib and ONT-993

    Measured: Up to 26 days

  16. AUC from time 0 to the time of the last quantifiable concentration for tucatinib and ONT-993

    Measured: Up to 26 days

  17. Percentage of AUC[0-inf] due to extrapolation for tucatinib and ONT-993

    Measured: Up to 26 days

  18. Maximum observed concentration for tucatinib and ONT-993

    Measured: Up to 26 days

  19. Time of maximum observed concentration for tucatinib and ONT-993

    Measured: Up to 26 days

  20. Apparent terminal elimination half-life for tucatinib and ONT-993

    Measured: Up to 26 days

  21. Apparent total clearance for tucatinib

    Measured: Up to 26 days

  22. Apparent volume of distribution during the terminal phase for tucatinib

    Measured: Up to 26 days

  23. Metabolic ratio based on AUC for ONT-993

    Measured: Up to 26 days

  24. Incidence of adverse events (AEs)

    Measured: Up to 32 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2018
  2. Study start6 Dec 2018
  3. Primary completion11 Mar 2019
  4. Study completion11 Mar 2019

Resources

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
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777761
Sponsor's protocol ID
ONT-380-011
Status last verified
Apr 2019
First submitted
10 Dec 2018
Last updated
12 Apr 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Topletz-Erickson AR, Mayor JG, Liu HT, Abdulrasool LI, Endres CJ. Effect of Tucatinib on Cardiac Repolarization in Healthy Volunteers. Drugs R D. 2023 Dec;23(4):411-419. doi: 10.1007/s40268-023-00440-8. Epub 2023 Sep 26.

    PubMed 37751113

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tucatinib and moxifloxacin 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 5 inclusion and 8 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 12 Apr 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?

Placebo-corrected change-from-baseline in QTcF (time frame: Up to 32 days). 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 NCT03777761, 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 12 Apr 2019.

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