Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-137 · 1 trial · 1 indication
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. ...
TAK-137 is an investigational small molecule being studied for dose finding purposes in a Phase 1 clinical trial. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of escalating single doses of TAK-137 in healthy participants. It is not approved for any indication and remains in clinical development.
TAK-137 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting a Phase 1 clinical trial to assess the drug's safety, tolerability, and pharmacokinetics in healthy participants. TAK-137 is an investigational small molecule.
TAK-137 is in Phase 1 clinical development. The Phase 1 trial is a randomized, double-blind, placebo-controlled study that has been completed. The trial enrolled 47 healthy participants and evaluated escalating single doses of TAK-137. TAK-137 is investigational and not yet approved.
TAK-137 has one completed Phase 1 clinical trial registered as NCT02334982. The study, titled "Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants," enrolled 47 healthy volunteers aged 18 years and older. The trial was randomized, double-blind, and placebo-controlled.
TAK-137 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development. The completed Phase 1 trial focused on safety, tolerability, and pharmacokinetics in healthy participants. TAK-137 has not been approved for any medical use.