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A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03482453
Recruitment Status : Completed
First Posted : March 29, 2018
Results First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief Summary:
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative to a reference (Process A) DiC of TAK-788 in healthy participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: TAK-788 Drug: Placebo Phase 1

Detailed Description:

The drug being tested in this study is called TAK-788. The study will assess the safety and tolerability of single oral dose of TAK-788, evaluate the effect of a low-fat meal on PK of TAK-788 and will assess the relative bioavailability of two DiCs of TAK-788.

The study will enroll approximately 69 participants. The study is designed to consist of 3 parts: Part 1- dose escalation phase, Part 2- low fat meal effect and Part 3 - relative bioavailability. The study population of Part 1 will consist of 40 participants enrolled into 5 cohorts. Each cohort will have 8 randomized participants with 6 receiving a single dose of TAK-788, and 2 receiving matching placebo under fasted conditions. In Cohorts 1 to 5, safety of single-dose TAK-788 will be evaluated. For Part 2, the effect of a low-fat meal on a single tolerable dose of TAK-788 will be determined following review of safety and tolerability data from the previous cohorts in Part 1. The study population of Part 2 will consist of 16 participants enrolled into 2 cohorts of different doses, where participants will be randomized to a cross-over sequence of:

  • TAK-788 Fed + TAK-788 Fasted
  • TAK-788 Fasted + TAK-788 Fed

The study population of Part 3 will consist of 13 participants enrolled into 1 cohort, where participants will be randomized to a cross-over sequence of:

  • TAK-788 DiC (reference) + TAK-788 DiC (test)
  • TAK-788 DiC (test) + TAK-788 DiC (reference) This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 7 months. Participants will be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Rising Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of TAK-788 Followed by Open-Label, Crossover Evaluation of the Effects of a Low-Fat Meal on TAK-788 Pharmacokinetics and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Subjects
Actual Study Start Date : March 28, 2018
Actual Primary Completion Date : December 22, 2018
Actual Study Completion Date : January 18, 2019

Arm Intervention/treatment
Experimental: Part 1 Cohort 1: TAK-788
TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Drug: Placebo
TAK-788 placebo-matching capsules.

Experimental: Part 1 Cohort 2: TAK-788
TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 1.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Drug: Placebo
TAK-788 placebo-matching capsules.

Experimental: Part 1 Cohort 3: TAK-788
TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 2.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Drug: Placebo
TAK-788 placebo-matching capsules.

Experimental: Part 1 Cohort 4: TAK-788
TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 3.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Drug: Placebo
TAK-788 placebo-matching capsules.

Experimental: Part 1 Cohort 5: TAK-788
TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 4.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Drug: Placebo
TAK-788 placebo-matching capsules.

Experimental: Part 2: TAK-788 Fed + TAK-788 Fasted
TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Experimental: Part 2: TAK-788 Fasted + TAK-788 Fed
TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Experimental: Part 3: TAK-788 DiC (reference) + TAK-788 DiC (test)
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.
Drug: TAK-788
TAK-788 DiC.
Other Name: AP32788

Experimental: Part 3: TAK-788 DiC (test) + TAK-788 DiC (reference)
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.
Drug: TAK-788
TAK-788 DiC.
Other Name: AP32788




Primary Outcome Measures :
  1. Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 30 days after the last dose of study drug (Day 31) ]
  2. Part 1: Number of Participants With One or More Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after the last dose of study drug (Day 31) ]
  3. Part 1: Number of Participants With Clinically Significant Abnormal Laboratory Values [ Time Frame: Baseline up to 30 days after the last dose of study drug (Day 31) ]
  4. Part 1: Number of Participants With Clinically Significant Abnormal Vital Signs [ Time Frame: Baseline up to 30 days after the last dose of study drug (Day 31) ]
  5. Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose ]
  6. Part 3, Cmax: Maximum Observed Plasma Concentration for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  7. Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose ]
  8. Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  9. Part 2, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose ]
  10. Part 3, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  11. Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose ]
  12. Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  13. Part 2, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose ]
  14. Part 3, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]

Secondary Outcome Measures :
  1. Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose ]
  2. Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose ]
  3. Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose ]
  4. Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose ]
  5. Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose ]
  6. Parts 2 and 3: Number of Participants Reporting One or More TEAEs [ Time Frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2) ]
  7. Parts 2 and 3: Number of Participants With One or More SAEs [ Time Frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2) ]
  8. Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Laboratory Values [ Time Frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2) ]
  9. Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Vital Signs [ Time Frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Body weight of greater than or equal to (>=) 45 kilogram (kg) (women) or >=55 kg (men) and a body mass index of 18.0 to 30.0 kilogram per square meter (kg/m^2) at screening.
  2. Nonsmoker (never smoked or greater than [>] 20 years from last occurrence of smoking).
  3. Normal organ function including hepatic, renal, and bone marrow function.

Exclusion Criteria:

  1. Manifestations of malabsorption due to prior gastro-intestinal (GI) surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-788.
  2. Pulmonary infection ongoing or within 30 days of informed consent.
  3. Inability to undergo venipuncture and/or tolerate venous access.
  4. Inability to tolerate multiple blood sampling.
  5. Ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics.

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): NCT03482453


Locations
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United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Director Millennium Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Study Protocol  [PDF] November 13, 2018
Statistical Analysis Plan  [PDF] March 27, 2019


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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03482453    
Other Study ID Numbers: TAK-788-1001
U1111-1208-9582 ( Other Identifier: WHO )
First Posted: March 29, 2018    Key Record Dates
Results First Posted: January 29, 2020
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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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 ( Millennium Pharmaceuticals, Inc. ):
Drug Therapy