Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants

NCT ID: NCT04454918

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2020-09-30

Brief Summary

The purpose of this study is to determine ABA of TAK-906 following single oral (capsule) administration of 50 milligram (mg) of TAK-906 and single intravenous (IV) microtracer dose administration of 100 microgram (μg) (approximately 1 microcurie [μCi]) of [14C]-TAK-906 in Period 1 (ABA), and to determine the mass balance of TAK-906 in urine and feces following a single oral (solution) administration of 50 mg (approximately 100 μCi) of [14C]-TAK-906 in Period 2 (absorption, distribution, metabolism, and elimination [ADME]).

Detailed Description

The drug being tested in this study is called TAK-906. The study will determine ABA in Period 1, and ADME, and mass balance of TAK-906 after single oral administration in Period 2 in healthy adult male participants. Plasma and urine samples will be collected for PK determination; plasma, whole blood, urine, and feces samples will be collected for total radioactivity (TRA) determination; and plasma, urine, and feces samples will be collected to characterize the metabolite profiles of TAK-906.

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 (ABA study period), all participants will receive single unlabeled oral 50 mg dose of TAK-906 as capsule followed by microdose of 100 μg (approximately 1 μCi) [14C]-TAK-906 as intravenous infusion followed by a washout period of at least 7 days before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a single dose of 50 mg (approximately 100 μCi) [14C]-TAK-906 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.

Conditions

Healthy Volunteers

Study Design

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

Study Groups

TAK-906 50 mg + [14C]-TAK-906 100 mcg + [14C]-TAK-906 50 mg

TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 micrograms (μg) \[approximately 1 microcurie (μCi)\], IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by \[14C\]-TAK-906 50 mg (approximately 100 μCi), solution, orally, once on Day 1 of Treatment Period 2.

Group Type: EXPERIMENTAL

TAK-906 Oral Capsule

Intervention Type: DRUG

TAK-906 capsule.

[14C]-TAK-906 Intravenous Infusion

Intervention Type: DRUG

\[14C\]-TAK-906 intravenous infusion.

[14C]-TAK-906 Oral Solution

Intervention Type: DRUG

\[14C\]-TAK-906 oral solution.

Interventions

TAK-906 Oral Capsule

TAK-906 capsule.

Intervention Type: DRUG

[14C]-TAK-906 Intravenous Infusion

\[14C\]-TAK-906 intravenous infusion.

Intervention Type: DRUG

[14C]-TAK-906 Oral Solution

\[14C\]-TAK-906 oral solution.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study.

2. Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (˂) 30.0 kilogram per square meter (kg/m^2) at screening.

Exclusion Criteria

1. QT interval corrected for heart rate using Fridericia's formula (QTcF) interval is greater than (>) 450 millisecond (msec) or Electrocardiogram (ECG) findings are deemed abnormal with clinical significance by the Investigator or designee at screening.

2. Estimated creatinine clearance less than (<) 90 milliliter per minute (mL/min) at screening.

3. 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.

4. Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.

5. 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 last 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 International Commission on Radiological Protection [ICRP] of 3000 milli roentgen equivalent man [mrem]).

6. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.

7. Donation of blood or significant blood loss within 56 days prior to the first dosing.

8. Plasma donation within 7 days prior to the first dosing.

9. Unable to refrain from or anticipates the use of:

• Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Acetaminophen (up to 2 g per 24 hour period) and Milk of Magnesia® (that is, magnesium hydroxide [less than or equal to (<=) 60 mL per day after Day 3 in Period 1 and after Day 8 in Period 2]) may be permitted during the study, only after dosing, if necessary to treat adverse events (AEs). Additional administration of Milk of Magnesia® may be administered on other days at discretion of the Investigator.
• Any drugs known to significantly affect the absorption, distribution, metabolism or elimination of TAK-906 within 28 days prior to the first dosing and throughout the study. Appropriate sources (example, Flockhart Table TM) will be consulted to confirm lack of PK/pharmacodynamics interaction with study drug.

• Minimum Eligible Age: 19 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

Celerion

Lincoln, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1254-4588

Identifier Type: OTHER

Identifier Source: secondary_id

TAK-906-1007

Identifier Type: -

Identifier Source: org_study_id