Status:
COMPLETED
A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine: Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of 50 microgram (mcg) (approximately 2 microcurie \[mcCi\]) \[14 C...
Detailed Description
The drug being tested in this study is called mobocertinib. The study will determine ABA of mobocertinib following single microdose of 50 mcg \[14C\]-mobocertinib and single oral administration of 160...
Eligibility Criteria
Inclusion
- Continuous non smoker who has not used nicotine containing products for at least 20 years prior to the first dosing and throughout the study, based on subject self-reporting.
- Body mass index greater than or equal to (\>=)18 and less than (˂) 30.0 kilogram per square meter (kg/m\^2) at screening.
Exclusion
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- Has history or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Has positive urine drug or alcohol results at screening or first check in.
- Estimated creatinine clearance \< 80 milliliter per minute (mL/min) at screening.
- Has tattoo(s) or scarring at or near the site of intravenous (IV) infusion or any other condition which may interfere with infusion site examination, in the opinion of the investigator.
- Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
- Has recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of first dosing.
- Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of first dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe (that is., weighted annual limit recommended by the Commission on Radiological Protection \[ICRP\] of 3000 millirem).
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03811834
Start Date
January 22 2019
End Date
March 11 2019
Last Update
February 12 2024
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502