HealthyPhase 1NCT03758339
A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants
A Phase 1 study testing tucatinib in people with Healthy, run by Cascadian Therapeutics Inc. at 1 site in United States.
Trial 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. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2017to 30 Jan 2018
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
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
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.
Read the 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.
- 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
Single dose of 300 mg of [¹⁴C]-tucatinib containing approximately 150 μCi of [¹⁴C] radioactivity
| Study group | Role | What they receive |
|---|---|---|
| Tucatinib | Experimental | Not described Receives: Drug: tucatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf])
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Measured: Up to 14 days
AUC from time 0 to last quantifiable concentration
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Measured: Up to 14 days
Maximum observed concentration
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Measured: Up to 14 days
Time of maximum observed concentration
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Measured: Up to 14 days
Apparent terminal elimination half-life
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Measured: Up to 14 days
Apparent total clearance
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
Measured: Up to 14 days
Apparent volume of distribution
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
Measured: Up to 14 days
AUC[0-inf] plasma tucatinib/total radioactivity ratio
AUC[0-inf] of plasma tucatinib relative to AUC[0-inf] of plasma total radioactivity
Measured: Up to 14 days
AUC[0-inf] blood/plasma ratio
AUC[0-inf] of whole blood total radioactivity to AUC[0-inf] of plasma total radioactivity
Measured: Up to 14 days
Amount excreted in urine (Aeu)
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
Measured: Up to 14 days
Cumulative Aeu
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
Measured: Up to 14 days
Percentage excreted in urine (Feu)
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
Measured: Up to 14 days
Cumulative Feu
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
Measured: Up 14 days
Renal clearance
PK outcome endpoint of tucatinib derived from urine collections
Measured: Up to 14 days
Amount excreted in feces [Aef]
PK outcome endpoint of total radioactivity derived from feces collection
Measured: Up to 14 days
Cumulative Aef
PK outcome endpoint of total radioactivity derived from feces collection
Measured: Up to 14 days
Percentage excreted in feces [Fef]
PK outcome endpoint of total radioactivity derived from feces collection
Measured: Up to 14 days
Cumulative Fef
PK outcome endpoint of total radioactivity derived from feces collection
Measured: Up to 14 days
Secondary outcomes (3)
Relative abundance of tucatinib and its metabolites eliminated in urine and feces
Measured: Up to 14 days
Relative abundance of tucatinib and its metabolites in plasma
Measured: Up to 14 days
Incidence of adverse events (AEs)
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start30 Dec 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cascadian Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Vo, PhD, Study director, Cascadian Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758339
- Sponsor's protocol ID
- ONT-380-008
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03758339
- Acronym / sponsor ID
- ONT-380-008
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cascadian Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 29 Nov 2018 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucatinib | Experimental | Drug: tucatinib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| tucatinibSingle dose of 300 mg of [¹⁴C]-tucatinib containing approximately 150 μCi of [¹⁴C] radioactivity | Drug | Tucatinib |
Primary outcome
Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf])
Time frame: Up to 14 days
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
AUC from time 0 to last quantifiable concentration
Time frame: Up to 14 days
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Maximum observed concentration
Time frame: Up to 14 days
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Time of maximum observed concentration
Time frame: Up to 14 days
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Apparent terminal elimination half-life
Time frame: Up to 14 days
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Apparent total clearance
Time frame: Up to 14 days
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
Apparent volume of distribution
Time frame: Up to 14 days
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
AUC[0-inf] plasma tucatinib/total radioactivity ratio
Time frame: Up to 14 days
AUC[0-inf] of plasma tucatinib relative to AUC[0-inf] of plasma total radioactivity
AUC[0-inf] blood/plasma ratio
Time frame: Up to 14 days
AUC[0-inf] of whole blood total radioactivity to AUC[0-inf] of plasma total radioactivity
Amount excreted in urine (Aeu)
Time frame: Up to 14 days
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
Cumulative Aeu
Time frame: Up to 14 days
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
Percentage excreted in urine (Feu)
Time frame: Up to 14 days
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
Cumulative Feu
Time frame: Up 14 days
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
Renal clearance
Time frame: Up to 14 days
PK outcome endpoint of tucatinib derived from urine collections
Amount excreted in feces [Aef]
Time frame: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
Cumulative Aef
Time frame: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
Percentage excreted in feces [Fef]
Time frame: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
Cumulative Fef
Time frame: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
3 secondary outcomes
Relative abundance of tucatinib and its metabolites eliminated in urine and feces
Time frame: Up to 14 days
Relative abundance of tucatinib and its metabolites in plasma
Time frame: Up to 14 days
Incidence of adverse events (AEs)
Time frame: Up to 14 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 29 Nov 2018.
- 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.
Alex Vo, PhD study director
Cascadian Therapeutics 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 Cascadian Therapeutics 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 6 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 29 Nov 2018. 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?
Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf]) (time frame: Up to 14 days). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2018.