Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-058 · 2 trials · 2 indications
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 (TEAE) 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 (chemistry and hematology) collected throughout study.
The percentage of participants with any markedly abnormal standard vital sign values collected throughout study. Vital signs included blood pressure (after 5 minutes supine and at 1 and 3 minutes after standing), pulse and oral temperature.
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 Non-elderly Healthy: TAK-058 25 mg | EXPERIMENTAL | TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. |
| Cohort 2 Non-elderly Healthy: TAK-058 75 mg | EXPERIMENTAL | TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. |
| Cohort 3 Non-elderly Healthy: TAK-058 150 mg | EXPERIMENTAL | TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. |
| Cohort 4 Elderly Healthy: TAK-058 25 mg | EXPERIMENTAL | TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants. |
| Cohort 5 Non-elderly Healthy: TAK-058 300 mg | PLACEBO_COMPARATOR | TAK-058 300 mg solution, orally, once daily on Day 1, in non-elderly healthy participants. |
| Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo | PLACEBO_COMPARATOR | TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants. |
| Cohort 4 Elderly Healthy: Placebo | PLACEBO_COMPARATOR | TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. |
| 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 | DRUG | TAK-058 Solution |
| TAK-058 Placebo | DRUG | TAK-058 placebo-matching solution |
| TAK-058 (ENV8058) | DRUG | TAK-058 (ENV8058) oral solution |
| Placebo | DRUG | TAK-058 (ENV8058) placebo-matching oral solution |
Inclusion Criteria: * Ages for this study are 18 to 60 years for non-elderly and 18 to 65 years for elderly. * A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout...
TAK-058 is an investigational small molecule being studied in healthy volunteers for dose finding purposes. It is not approved for any disease and remains in early clinical development. Clinical trials have evaluated its safety, tolerability, and pharmacokinetics after single and multiple doses in healthy participants.
TAK-058 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has sponsored Phase 1 clinical trials of the drug in the United States.
TAK-058 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers.
TAK-058 has been studied in two completed Phase 1 trials. NCT02153099 evaluated safety, tolerability, and pharmacokinetics of escalating single doses in healthy participants. NCT02389881 evaluated safety, tolerability, and pharmacokinetics of multiple doses in healthy participants. Both trials were conducted in the United States.
Yes, TAK-058 is also known as ENV8058. One clinical trial, NCT02153099, used the name ENV8058 in its title while referring to the same drug. Both names refer to the same investigational small molecule.