PRA Health Sciences
Salt Lake City, Utah, 84124, United States
NCT Number: NCT03482453
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Salt Lake City, Utah, 84124, United States
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:
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TAK-788 capsules.
Other names: AP32788
TAK-788 placebo-matching capsules.
Time frame: Baseline up to 30 days after the last dose of study drug (Day 31)
Time frame: Baseline up to 30 days after the last dose of study drug (Day 31)
Time frame: Baseline up to 30 days after the last dose of study drug (Day 31)
Time frame: Baseline up to 30 days after the last dose of study drug (Day 31)
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Time frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Time frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Time frame: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Millennium Pharmaceuticals, Inc.
Industry
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
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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