Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TAK-058 (ENV8058)
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 developed by Takeda Pharmaceutical Company Limited. It has been studied in Phase 1 clinical trials in healthy adult volunteers, evaluating safety, tolerability, and pharmacokinetics. The specific disease indications for which TAK-058 is being developed have not been publicly disclosed.
TAK-058 is made by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the developer responsible for the clinical program, including the Phase 1 trials conducted in the United States.
TAK-058 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA for any indication.
TAK-058 has been evaluated in two completed Phase 1 trials. NCT02153099 tested escalating single doses of ENV8058 (TAK-058) in 48 healthy participants. NCT02389881 tested multiple doses of TAK-058 in 40 healthy participants. Both were randomized, double-blind, placebo-controlled studies conducted in the United States.
Yes, TAK-058 is also known as ENV8058. The two names refer to the same investigational small molecule. One of its Phase 1 trials, NCT02153099, is listed under the name ENV8058 (TAK-058), confirming they are identical.