A Study to Assess Absolute Bioavailability (ABA) of TAK-788 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-TAK-788 in Male Healthy Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:19 - 55
Updated:3/23/2019
Start Date:January 22, 2019
End Date:March 11, 2019

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A Phase 1 Study to Assess Absolute Bioavailability of TAK-788 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]-TAK-788 in Male Healthy Subjects

The purpose of this study is to determine:

Period 1 (ABA): ABA of TAK-788 following single microdose intravenous administration of 50
microgram (mcg) (approximately 2 microcurie [mcCi]) [14 C]-]-TAK-788 and single oral
administration of 160 milligram (mg) TAK-788.

Period 2 (absorption, distribution, metabolism, and elimination [ADME]): the mass balance and
metabolic profile of TAK-788 in plasma, urine, and feces, to characterize the PK of TAK-788
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]-TAK-788 solution.

The drug being tested in this study is called TAK-788. The study will determine ABA of
TAK-788 following single microdose of 50 mcg [14C]-TAK-788 and single oral administration of
160 mg TAK-788 and will assess the mass balance and metabolic profile of TAK-788 in plasma,
urine, and feces following a single oral administration of 160 mg [14C]-TAK 788 solution, and
will characterize the PK of TAK-788 and its metabolites in plasma, whole blood, and urine,
and total radioactivity concentration equivalents in plasma and whole blood following a
single dose of 160 mg [14C]-TAK-788.

The study will enroll approximately 6 participants. The study is designed to consist of 2
periods: Period 1 (ABA study period) and Period 2 (ADME study period). In Period 1, all
participants will receive single unlabeled oral 160 mg dose of TAK-788 as capsules. Post oral
dosing, participants will receive 15-minute intravenous infusion of a microdose of 50 mcg
(approximately 2mcCi) [14C]-TAK-788. In Period 2, participants will receive single dose of
160 mg (approximately 100 mcCi) [14C]-TAK-788 as an oral solution.

This single center trial will be conducted in the United States. The overall time to
participate in this study is approximately 65 days including screening period. Participants
will be contacted approximately 30 days after the last dose of study drug for a follow-up
assessment.

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 mililiter 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.
We found this trial at
1
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Lincoln, Nebraska 68502
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Lincoln, NE
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