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
Condition: Healthy Volunteers
Intervention: Mobocertinib
Intervention description: Mobocertinib capsule, [14C]-Mobocertinib intravenous infusion, [14C]-Mobocertinib oral solution.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Male
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

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]-]-mobocertinib and single oral
      administration of 160 milligram (mg) mobocertinib.

      Period 2 (absorption, distribution, metabolism, and elimination [ADME]): the mass balance and
      metabolic profile of mobocertinib in plasma, urine, and feces, to characterize the PK of
      mobocertinib and its metabolites (AP32960 and AP32914) in plasma, whole blood, and urine, and
      total radioactivity concentration equivalents in plasma and whole blood following a single
      oral administration of 160 mg (approximately 100 mcCi) [14C]-mobocertinib solution.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Body mass index greater than or equal to (>=)18 and less than (˂) 30.0 kilogram per
             square meter (kg/m^2) at screening.

        Exclusion Criteria:

          1. 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.

          2. Has history or presence of alcoholism or drug abuse within the past 2 years prior to
             the first dosing.

          3. Has positive urine drug or alcohol results at screening or first check in.

          4. Estimated creatinine clearance < 80 milliliter per minute (mL/min) at screening.

          5. 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.

          6. Has infrequent bowel movements (less than approximately once per day) within 30 days
             prior to first dosing.

          7. Has recent history of abnormal bowel movements, such as diarrhea, loose stools, or
             constipation, within 2 weeks of first dosing.

          8. 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).

          9. Donation of blood or significant blood loss within 56 days prior to the first dosing.

         10. Plasma donation within 7 days prior to the first dosing.