A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants

Millennium Pharmaceuticals, Inc.6 enrolled

Overview

The purpose of this study is to determine the mass balance, routes of elimination and characterize the metabolic profiles of a single intravenous dose of \[14C\]-TAK-954, identify major circulating and excreted metabolites. This study will also determine the single-dose PK of total radioactivity, TAK-954 and its metabolites where possible.

The drug being tested in this study is called TAK-954. This study will assess the mass balance, metabolic profiles and routes of elimination of single intravenous dose of \[14C\]-TAK-954, and will determine the major circulating and excreted metabolites and single-dose PK of total radioactivity, TAK-954, THRX513466, and THRX 913682 in healthy male participants. The study will enroll approximately 6 participants. All participants will receive a single dose of \[14C\]-TAK-954 0.5 mg on Day 1. This single-center trial will be conducted in Netherlands. The overall time to participate in this study is approximately 6 to 7 weeks. Participants will make a final visit to the clinic 15 days after last dose of study drug for a follow-up assessment.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

[14C]-TAK-954DRUG

\[14C\]-TAK-954 intravenous infusion.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be a man aged 18 to 55 years, inclusive, at the screening visit. 2. Have a body mass index (BMI) greater than or equal to (\>=) 18 and less than or equal to (\<=) 30 kilogram per square meter (kg/m\^2) and a body weight greater than (\>) 50 kilogram (kg) at the screening visit. 3. Be a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug. 4. Meet the following birth control requirements: * Is a male participant who is sterile or agrees to use an appropriate method of contraception, including a condom, from the first dose of study drug until 30 days after the last dose of study drug. No restrictions are required for a vasectomized male participant provided that the participant is at least 1 year postbilateral vasectomy procedure before the first dose of study drug. A male participant whose vasectomy procedure was performed less than 1 year before the first dose of study drug must follow the same restrictions as a nonvasectomized man. Appropriate documentation of surgical procedures should be provided. * Is a male participant who agrees to not donate sperm from trial drug administration on the first day of the first dose until 30 days after the last dose of study drug. Exclusion Criteria: 1. Has total 14C radioactivity measured by accelerator mass spectrometry in plasma (during screening) exceeding 14C/12C ratio 1.1E-12. 2. Participated in any study with a radiation dose above 0.1 millibecquerel (MBq) or radiation burden above 0.1 millisievert (mSv) within 1 year before screening. 3. Was exposed to significant radiation (example, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months before check-in. 4. Irregular defecation pattern (less than once per 2 days). 5. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to beer 354 milliliter \[mL\]/12 ounce \[oz\], wine 118 mL/4 oz, or distilled spirits 29.5 mL/1 oz). 6. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. 7. Has a substance abuse disorder.

Locations (1)

PRAHS

Groningen, Netherlands

Outcomes

Primary Outcomes

Cumulative Percentage of Administered Radioactivity Recovered in Urine

Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose

Cumulative Percentage of Administered Radioactivity Recovered in Feces

Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose

Cumulative Percentage of Radioactivity in Urine and Feces Combined

Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose

Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined

Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.

Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine

Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.

Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces

Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.

Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Mean Percent of Total Radioactivity in Plasma for TAK-954 and TAK-954 Metabolites

Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Data from ClinicalTrials.gov

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Cumulative Percentage of Dose Excreted in Urine for TAK-954

Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose

Cumulative Percentage of Dose Excreted in Feces for TAK-954

The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.

Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954