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

NCT04454918 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-906-1007U1111-1254-4588
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 \[ADME\]).

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Period 1: Absolute Bioavailability Based on Ratio of Dose Normalized Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞ ) for TAK-906

  Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability for plasma TAK-906, calculated as geometric least squares mean ratio: \[Actual Dose (IV) x AUC∞ (oral)\] / \[Actual Dose (oral) x AUC∞ (IV)\] multiplied (x) 100, where AUC∞ for IV infusion was normalized to a 50 mg dose.

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1

• Period 2: Cum%Dose (UR): Cumulative Percentage of Total Radioactivity Excreted in Urine for [14C]-TAK-906

  Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2

• Period 2: Cum%Dose (FE): Cumulative Percentage of Total Radioactivity Excreted in Feces for [14C]-TAK-906

  Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2

• Period 2: Combined Cum%Dose: Cumulative Combined Percent of Total Radioactivity Excreted in Urine and Feces for [14C]-TAK-906

  Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2

Secondary Outcomes (36)

• Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-906 and Metabolite (M23) After Oral Administration

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1

• Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1

• Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1

• Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1

• Period 1: t(1/2)z : Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: TAK-906 Oral Capsule; Drug: [14C]-TAK-906 Intravenous Infusion; Drug: [14C]-TAK-906 Oral Solution

Interventions

TAK-906 Oral Capsule DRUG

TAK-906 capsule.

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

[14C]-TAK-906 Intravenous Infusion DRUG

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

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

[14C]-TAK-906 Oral Solution DRUG

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

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

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Estimated creatinine clearance less than (\<) 90 milliliter per minute (mL/min) at screening.
• 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.
• Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
• 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 \[mrem\]).
• 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.
• Donation of blood or significant blood loss within 56 days prior to the first dosing.
• Plasma donation within 7 days prior to the first dosing.
• 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.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

trazpiroben

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: July 30, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: March 7, 2022
• Results First Posted: March 7, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)