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

NCT ID: NCT03500224

Last Updated: 2019-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2018-06-01

Brief Summary

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.

Detailed Description

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[14C]-TAK-954 0.5 mg

\[14C\]-TAK-954 0.5 milligram (mg), (containing approximately 1.5 microcurie \[µCi\] of radioactive tracer), administered as 60-minute infusion, intravenously, once on Day 1.

Group Type: EXPERIMENTAL

[14C]-TAK-954

Intervention Type: DRUG

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

Interventions

[14C]-TAK-954

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

PRAHS

Groningen, , Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1202-5762

Identifier Type: OTHER

Identifier Source: secondary_id

NL65503.056.18

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-001181-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TAK-954-1005

Identifier Type: -

Identifier Source: org_study_id