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

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ClinicalTrials.gov Identifier: NCT02906813
Recruitment Status : Completed
First Posted : September 20, 2016
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: TAK-935 Tablets Drug: TAK-935 Oral Solution Phase 1

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : October 12, 2016
Actual Study Completion Date : November 9, 2016

Arm Intervention/treatment
Experimental: TAK-935 300 mg (Tablets Fed+Tablets Fasted+Solution Fasted)
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
Tablets

Drug: TAK-935 Oral Solution
Oral solution

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

Drug: TAK-935 Oral Solution
Oral solution

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

Drug: TAK-935 Oral Solution
Oral solution




Primary Outcome Measures :
  1. Cmax: Maximum Observed Plasma Concentration for TAK-935 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  2. AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  3. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose ]

Secondary Outcome Measures :
  1. Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) [ Time Frame: Baseline up to 30 days after last dose of study drug (Day 39) ]
  2. Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose [ Time Frame: Baseline up to Day 11 ]
  3. Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose. [ Time Frame: Baseline up to Day 11 ]
  4. Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose [ Time Frame: Baseline up to Day 11 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906813


Locations
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United States, California
Glendale, California, United States
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02906813     History of Changes
Other Study ID Numbers: TAK-935-1005
U1111-1177-8044 ( Registry Identifier: WHO )
First Posted: September 20, 2016    Key Record Dates
Results First Posted: September 19, 2018
Last Update Posted: September 19, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Pharmaceutical Solutions