Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02723201 | TAK-020 Relative Bioavailability and Food Effect Study in Healthy Participants | PHASE1 | COMPLETED | 25 | — | — | Apr 28, 2016 | Aug 24, 2016 | Apr 13, 2018 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Part-1, Period 1: TAK-020 17.5 mg Oral Solution | EXPERIMENTAL | Single dose 17.5 milligram (mg), on Day 1, followed by 7 days of washout. Dose will be determined from TAK-020 single rising dose (SRD) trial. |
| Part-1, Period 2: TAK-020 17.5 mg Co-crystal Tablet (CCT) | EXPERIMENTAL | Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. |
| Part-1, Period 3:TAK-020 17.5 mg Solid Dispersion Tablet (SDT) | EXPERIMENTAL | Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. |
| Part-1, Period 4:TAK-020 17.5 mg Immediate Release Tablet(IRT) | EXPERIMENTAL | Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. |
| Part 2, Period 1: TAK-020 25 mg CCT | EXPERIMENTAL | Participants will be randomized to AB or BA crossover where A= Fasted, B =Fed. Sequence I: Single oral dose TAK-020 25 mg, Fasted (A), 7 days washout, single oral dose TAK-020 Fed (B) Sequence II: Single oral dose TAK-020 25 mg, Fed (B), 7 days washout, single oral dose TAK-020 Fasted (A) Dose will be determined from SRD trial and Part 1. |
| Part- 3 Cohort 1: TAK-020 Solid Formulation | EXPERIMENTAL | Single oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2 |
| Part 3 Cohort 2: TAK-020 Solid Formulation | EXPERIMENTAL | Single oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2 |
| Name | Type | Description |
|---|---|---|
| TAK-020 Captisol Oral Solution | DRUG | TAK-020 solution. |
| TAK-020 CCT | DRUG | TAK-020 co-crystal tablet |
| TAK-020 SDT | DRUG | TAK-020 Solid dispersion tablet. |
| TAK-020 IRT | DRUG | TAK-020 immediate release tablet. |
| TAK-020 Solid Formulation | DRUG | TAK-020 solid formulation |
Inclusion Criteria: 1. Is capable of understanding and complying with protocol requirements. 2. Is legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a pa...