Bioavailability and Food Effect Study of Two Formulations of TAK-906

NCT04831502 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: TAK-906-1005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when taken with a high fat high calorie breakfast compared to fasting. This study will require participants to stay at the clinical research unit for about 3 weeks to be monitored after receiving TAK-906.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Secondary Outcomes (15)

• Number of Participants Reporting one or More Adverse Events (AEs)

  Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31)

• Number of Participants Reporting one or More Serious Adverse Events (SAEs)

  Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31)

• Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Study Arms (2)

Sequence 1: TAK 906 50 mg (Treatment A+Treatment B+Treatment A+Treatment B+Treatment C)

EXPERIMENTAL

Participants will receive TAK-906 50 milligram (mg) as Treatment A (TAK-906 capsule) and Treatment B (TAK-906 tablet) under fasted conditions and Treatment C (TAK-906 tablet) under fed conditions, orally, once on Day 1 of Periods 1 to 5. A washout interval of at least 3 days will be maintained between each Treatment Period.

Drug: TAK-906

Sequence 2: TAK-906 50 mg (Treatment B+Treatment A+Treatment B+Treatment A+Treatment C)

EXPERIMENTAL

Participants will receive TAK-906 50 mg as Treatment B (TAK-906 tablet) and Treatment A (TAK-906 capsule) under fasted conditions and Treatment C (TAK-906 tablet) under fed conditions, orally, once on Day 1 of Periods 1 to 5. A washout interval of at least 3 days will be maintained between each Treatment Period.

Drug: TAK-906

Interventions

TAK-906 DRUG

TAK-906 Tablets.

Sequence 1: TAK 906 50 mg (Treatment A+Treatment B+Treatment A+Treatment B+Treatment C); Sequence 2: TAK-906 50 mg (Treatment B+Treatment A+Treatment B+Treatment A+Treatment C)

Eligibility Criteria

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

You may qualify if:

• Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting and urine cotinine test.
• Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than (\<) 30.0 kilogram per square meter (kg/m\^2) at the screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs) performed at the screening visit and before administration of the initial dose of trial drug, as deemed by the investigator or designee.

You may not qualify if:

• Presence of infectious diseases (example, Coronavirus disease-19 \[COVID-19\] and flu) at the time of screening or check-in.
• Any history of major surgery that may affect absorption, metabolism or excretion of study drug (example, intestinal resections, hepatectomy, nephrectomy, cholecystectomy), and/or digestive organ resection (except appendectomy).
• History of any illness that, in the opinion of the investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
• History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
• Positive urine drug or alcohol results at screening or check-in.
• Positive urine cotinine at screening.
• Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• QT interval corrected for heart rate using Frederica's equation (QTcF) is greater than (\>) 450 milliseconds (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
• Estimated creatinine clearance \<90 milliliter per minute (mL/min) at screening.
• Unable to refrain from or anticipates the use of:
• o 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. After first dosing, acetaminophen (up to 2 grams \[g\] per 24 hours) may be administered at the discretion of the investigator or designee; sponsor must be consulted prior to administering acetaminophen to a participants.
• Has been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within 30 days prior to the first dosing and throughout the study.
• Is lactose intolerant or unable/unwilling to eat the high-fat, high-calorie breakfast.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Interventions

trazpiroben

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: April 2, 2021
• Primary Completion: February 2, 2022
• Study Completion: February 2, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

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)