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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Bioavailability and Food Effect Study to Compare Tablet Versus Solution Formulation and to Assess the Effect of Food on the Bioavailability of a Single TAK-935 Dose in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906813
• Other study ID #: TAK-935-1005
• Secondary ID: U1111-1177-8044
• Status: Completed
• Phase: Phase 1
• Start date: September 12, 2016
• Est. completion date: November 9, 2016

Study information

• Verified date: January 2018
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The drug being tested in this study is called TAK-935. The study will look at the relative BA of TAK-935 300 mg tablets compared to a TAK-935 300 mg oral solution and will assess the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

The study will enroll approximately 9 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 3 treatment sequences:

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

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

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

Administration of each dose will be separated by a washout period of at least 3 days. Participants will be asked to take single dose of TAK-935 tablet or oral solution on Day 1 of each Intervention Period.

This single center trial will be conducted in the United States. The overall time to participate in this study is 39 days. Participants will remain confined to the clinic from Day 1 of Intervention Period 1 to Day 3 of Intervention Period 3 and will be contacted by telephone 30 days after last dose of TAK-935 for a follow-up assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 9, 2016
• Est. primary completion date: October 12, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. 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.

Exclusion Criteria:

1. Has received TAK-935 in a previous clinical study or as a therapeutic agent.

2. Has a history of any psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria.

3. 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.

4. Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.

5. 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.

6. 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).

7. Has poor peripheral venous access.

8. 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TAK-935 Tablets
Tablets
• TAK-935 Oral Solution
Oral solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Plasma Concentration for TAK-935		Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Primary	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
Primary	AUC8: 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	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)
Secondary	Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose		Baseline up to Day 11
Secondary	Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose.		Baseline up to Day 11
Secondary	Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose		Baseline up to Day 11