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 developed by Takeda Pharmaceutical Company Limited. It has been studied in a Phase 1 clinical trial involving healthy adult participants. The specific disease or condition it is intended to treat has not been disclosed.
TAK-137 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the Phase 1 study of the compound. No partnership or licensing arrangement for TAK-137 has been announced.
TAK-137 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA for any indication.
TAK-137 was evaluated in a single Phase 1 trial, NCT02334982, titled Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants. The trial enrolled 47 healthy adult volunteers, was randomized, double-blind, and placebo-controlled, and has been completed.
The completed Phase 1 trial NCT02334982 assessed the safety, tolerability, and pharmacokinetics of escalating single doses of TAK-137 in healthy participants. It enrolled 47 adults aged 18 years and older of all sexes, used a randomized, double-blind, placebo-controlled design, and has concluded.