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A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03706469
Recruitment Status : Completed
First Posted : October 16, 2018
Results First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Tracking Information
First Submitted Date  ICMJE October 11, 2018
First Posted Date  ICMJE October 16, 2018
Results First Submitted Date  ICMJE December 2, 2019
Results First Posted Date  ICMJE December 23, 2019
Last Update Posted Date December 23, 2019
Actual Study Start Date  ICMJE October 18, 2018
Actual Primary Completion Date December 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  • AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  • Cmax: Maximum Observed Plasma Concentration for TAK-831 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) [ Time Frame: Day 1 post dose up to 14 days after the last dose of study drug (Up to Day 47) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) [ Time Frame: Day 1 post dose up to 14 days after the last dose of study drug (Day 47) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants
Official Title  ICMJE A Phase 1, Open-Label, Randomized, Single Dose, 5-Period, 5-Treatment Study to Evaluate the Relative Bioavailability and Effect of Food on TAK-831 Tablet Formulations in Healthy Subjects
Brief Summary The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.
Detailed Description

The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants to evaluate the relative BA and effect of food on the PK of TAK-831 tablet formulation.

The study will enroll approximately 16 participants. Participants will be randomly assigned (by chance, like flipping a coin) to TAK-831 in 1 of the 4 treatment sequences as following:

  • T2 50 mg Fasted + T3 50 mg Fasted + T3 600 mg Fasted + T2 600 mg Fasted + T3 600 mg Fed
  • T3 50 mg Fasted + T2 600 mg Fasted + T2 50 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed
  • T2 600 mg Fasted + T3 600 mg Fasted + T3 50 mg Fasted + T2 50 mg Fasted + T3 600 mg Fed
  • T3 600 mg Fasted + T2 50 mg Fasted + T2 600 mg Fasted + T3 50 mg Fasted + T3 600 mg Fed

All participants will be asked to take tablet of assigned TAK-831 on Day 1 of each treatment period.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 70 days. Participants will make multiple visits to the clinic and will be contacted by clinic approximately 14 days after the last dose of study drug for a follow-up assessment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: TAK-831 T2
    TAK-831 T2 Tablets.
  • Drug: TAK-831 T3
    TAK-831 T3 Tablets.
Study Arms  ICMJE
  • Experimental: Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)
    TAK-831 T2 50 milligram (mg), tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
    Interventions:
    • Drug: TAK-831 T2
    • Drug: TAK-831 T3
  • Experimental: Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)
    TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
    Interventions:
    • Drug: TAK-831 T2
    • Drug: TAK-831 T3
  • Experimental: Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)
    TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
    Interventions:
    • Drug: TAK-831 T2
    • Drug: TAK-831 T3
  • Experimental: Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)
    TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
    Interventions:
    • Drug: TAK-831 T2
    • Drug: TAK-831 T3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2018)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 22, 2018
Actual Primary Completion Date December 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. 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.

Exclusion Criteria:

  1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
  2. Smokes more than 20 cigarettes or equivalent per day within 3 months prior to the first dose and is unwilling to discontinue use of any tobacco- or nicotine-containing products during the confinement period(s) of the study.
  3. 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.
  4. Is lactose intolerant or unable/unwilling to eat the high-fat breakfast.
  5. Donation of blood or significant blood loss within 56 days prior to the first dosing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03706469
Other Study ID Numbers  ICMJE TAK-831-1006
U1111-1217-5483 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment
Responsible Party Takeda ( Millennium Pharmaceuticals, Inc. )
Study Sponsor  ICMJE Millennium Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Millennium Pharmaceuticals, Inc.
PRS Account Takeda
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP