A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants

NCT02906813 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-935-1005U1111-1177-8044
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration for TAK-935

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

• AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935

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

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935

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

Secondary Outcomes (4)

• Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

  Baseline up to 30 days after last dose of study drug (Day 39)

• Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose

  Baseline up to Day 11

• Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose.

  Baseline up to Day 11

• Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose

  Baseline up to Day 11

Study Arms (3)

TAK-935 300 mg (Tablets Fed+Tablets Fasted+Solution Fasted)

EXPERIMENTAL

TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 3.

Drug: TAK-935 Tablets; Drug: TAK-935 Oral Solution

TAK-935 300 mg (Tablets Fasted+Solution Fasted+Tablets Fed

EXPERIMENTAL

TAK-935 300 mg, tablets, orally under fasted state on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg tablets, orally, 30 minutes after high-fat meal on Day 1 of Intervention Period 3.

Drug: TAK-935 Tablets; Drug: TAK-935 Oral Solution

TAK-935 300 mg (Solution Fasted+Tablets Fed+Tablets Fasted)

EXPERIMENTAL

TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 1, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 2, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 3.

Drug: TAK-935 Tablets; Drug: TAK-935 Oral Solution

Interventions

TAK-935 Tablets DRUG

Tablets

TAK-935 300 mg (Solution Fasted+Tablets Fed+Tablets Fasted); TAK-935 300 mg (Tablets Fasted+Solution Fasted+Tablets Fed; TAK-935 300 mg (Tablets Fed+Tablets Fasted+Solution Fasted)

TAK-935 Oral Solution DRUG

Oral solution

TAK-935 300 mg (Solution Fasted+Tablets Fed+Tablets Fasted); TAK-935 300 mg (Tablets Fasted+Solution Fasted+Tablets Fed; TAK-935 300 mg (Tablets Fed+Tablets Fasted+Solution Fasted)

Eligibility Criteria

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

You may qualify if:

• \. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m\^2), inclusive at Screening and Day -2.

You may not qualify if:

• Has received TAK-935 in a previous clinical study or as a therapeutic agent.
• Has a history of any psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria.
• Has any lifetime history of drug abuse (defined as any illicit drug use) or any lifetime history of alcohol abuse prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or a single measure of spirits or 1 small glass of wine.
• Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
• Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody at Screening or a known history of human immunodeficiency virus infection.
• Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-In Day -1. Cotinine test is positive at Screening or Check-In (Day -1).
• Has poor peripheral venous access.
• Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1 of Period 1.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Glendale, California, United States

Location

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

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: September 15, 2016
• First Posted: September 20, 2016
• Study Start: September 12, 2016
• Primary Completion: October 12, 2016
• Study Completion: November 9, 2016
• Last Updated: September 19, 2018
• Results First Posted: September 19, 2018

Record last verified: 2018-01

Locations

US (1)