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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02153099 | Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of ENV8058 (TAK-058) in Healthy Participants | PHASE1 | COMPLETED | 48 | — | — | Jun 1, 2014 | Nov 1, 2014 | Dec 17, 2015 | 1 | United States |
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.
The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse \[beats per minute (bpm)\], and resting blood pressure and after standing.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: TAK-058 15 mg | EXPERIMENTAL | TAK-058 15 mg, 100 mL oral solution, once on Day 1. |
| Cohort 2: TAK-058 30 mg | EXPERIMENTAL | TAK-058 30 mg, 100 mL oral solution, once on Day 1. |
| Cohort 3: TAK-058 45 mg | EXPERIMENTAL | TAK-058 45 mg, 100 mL oral solution, once on Day 1. |
| Cohort 4: TAK-058 5 mg | EXPERIMENTAL | TAK-058 5 mg, 100 mL oral solution, once on Day 1. |
| Cohort 5: TAK-058 75 mg | EXPERIMENTAL | TAK-058 75 mg, 100 mL oral solution, once on Day 1. |
| Cohort 6: TAK-058 150 mg | EXPERIMENTAL | TAK-058 150 mg, 100 mL oral solution, once on Day 1. |
| Cohort 1-6: Placebo | PLACEBO_COMPARATOR | TAK-058 placebo-matching, 100 mL oral solution, once on Day 1. |
| Name | Type | Description |
|---|---|---|
| TAK-058 (ENV8058) | DRUG | TAK-058 (ENV8058) oral solution |
| Placebo | DRUG | TAK-058 (ENV8058) placebo-matching oral solution |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...