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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02413255 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers | PHASE1 | COMPLETED | 120 | — | — | Mar 18, 2015 | May 4, 2017 | Jan 7, 2019 | 1 | United States |
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Safety laboratory tests includes hematology, serum chemistries, and urinalysis.
Vital signs include oral temperature, respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse beats per minute (bpm).
A standard 12-lead ECG was performed. Change from baseline=CFB.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Safety laboratory tests include hematology, and serum chemistries.
Vital signs include oral temperature respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse (bpm).
A standard 12-lead ECG was performed.
| Arm | Type | Description |
|---|---|---|
| Part 1 Cohort 1-9: Placebo | PLACEBO_COMPARATOR | TAK-020 placebo-matching solution, orally, once on Day 1. |
| Part 1 Cohort 1: TAK-020 0.1 mg | EXPERIMENTAL | TAK-020 0.1 mg, solution, orally once on Day 1. |
| Part 1 Cohort 2: TAK-020 0.5 mg | EXPERIMENTAL | TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1. |
| Part 1 Cohort 3: TAK-020 2.5 mg | EXPERIMENTAL | TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2. |
| Part 1 Cohort 4: TAK-020 4.4 mg | EXPERIMENTAL | TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3. |
| Part 1 Cohort 5: TAK-020 8.8 mg | EXPERIMENTAL | TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4. |
| Part 1 Cohort 6: TAK-020 17.5 mg | EXPERIMENTAL | TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5. |
| Part 1 Cohort 7: TAK-020 35 mg | EXPERIMENTAL | TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 6. |
| Part 1 Cohort 8: TAK-020 70 mg | EXPERIMENTAL | TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 7. |
| Part 1 Cohort 9: TAK-020 105 mg | EXPERIMENTAL | TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 8. |
| Part 2 Cohort 1-6: Placebo | PLACEBO_COMPARATOR | TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9. |
| Part 2 Cohort 1: TAK-020 3.75 mg | EXPERIMENTAL | TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study. |
| Part 2 Cohort 2: TAK-020 5.75 mg | EXPERIMENTAL | TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2. |
| Part 2 Cohort 3: TAK-020 13 mg | EXPERIMENTAL | TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2. |
| Part 2 Cohort 4: TAK-020 25 mg | EXPERIMENTAL | TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2. |
| Part 2 Cohort 5: TAK-020 45 mg | EXPERIMENTAL | TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2. |
| Part 2 Cohort 6: TAK-020 60 mg | EXPERIMENTAL | TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2. |
| Name | Type | Description |
|---|---|---|
| TAK-020 | DRUG | TAK-020 oral solution |
| TAK-020 Placebo | DRUG | TAK-020 placebo-matching oral solution |
Inclusion Criteria Participant eligibility is determined according to the following criteria prior to entry into the study: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. Participant or, when applicable, the participa...