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Completed

NCT Number: NCT03482453

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Nonsmoker (never smoked or greater than [>] 20 years from last occurrence of smoking).
  • Normal organ function including hepatic, renal, and bone marrow function.

Exclusion criteria

  • 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.
  • Pulmonary infection ongoing or within 30 days of informed consent.
  • Inability to undergo venipuncture and/or tolerate venous access.
  • Inability to tolerate multiple blood sampling.
  • Ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics.

Treatment and study plan

TAK-788

Drug

TAK-788 capsules.

Other names: AP32788

Placebo

Drug

TAK-788 placebo-matching capsules.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Millennium Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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