Lincoln, Nebraska 68502


Purpose:

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.


Study summary:

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.


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 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.


NCT ID:

NCT03811834


Primary Contact:

Study Director
Medical Director
Millennium Pharmaceuticals, Inc.

Takeda Study Registration Call Center
Phone: +1-877-825-3327
Email: medicalinformation@tpna.com


Backup Contact:

N/A


Location Contact:

Lincoln, Nebraska 68502
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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