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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02334982 | Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants | PHASE1 | COMPLETED | 47 | — | — | Jun 1, 2013 | Jan 1, 2014 | Feb 10, 2015 | - | — |
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. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.
The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.
The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: TAK-137 2 mg | EXPERIMENTAL | TAK-137 2 mg, tablets, orally, once on Day 1. |
| Cohort 2: TAK-137 5 mg | EXPERIMENTAL | TAK-137 5 mg, tablets, orally, once on Day 1. |
| Cohort 3: TAK-137 10 mg | EXPERIMENTAL | TAK-137 10 mg, tablets, orally, once on Day 1. |
| Cohort 4: TAK-137 5 mg Food Effect | EXPERIMENTAL | TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2. |
| Cohort 5: TAK-137 0.5 mg | EXPERIMENTAL | TAK-137 0.5 mg, tablets, orally, once on Day 1. |
| Cohort 6: TAK-137 20 mg | EXPERIMENTAL | TAK-137 20 mg, tablets, orally, once on Day 1. |
| Cohorts 1-6: Placebo | PLACEBO_COMPARATOR | TAK-137 placebo-matching tablets, orally, once on Day 1. |
| Name | Type | Description |
|---|---|---|
| TAK-137 | DRUG | TAK-137 tablets |
| Placebo | DRUG | TAK-137 placebo-matching tablets |
Inclusion Criteria: 1. Is a healthy male or non-pregnant, non-lactating female adult who is 18 to 55 years of age inclusive at the time of informed consent and first study medication dose. 2. Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m\^2, inclusive at Screening. ...