Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-020 · 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. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Safety laboratory tests includes hematology, serum chemistries, and urinalysis.
Vital signs include oral temperature, respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse beats per minute (bpm).
A standard 12-lead ECG was performed. Change from baseline=CFB.
An 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. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Safety laboratory tests include hematology, and serum chemistries.
Vital signs include oral temperature respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse (bpm).
A standard 12-lead ECG was performed.
| Arm | Type | Description |
|---|---|---|
| Part 1 Cohort 1-9: Placebo | PLACEBO_COMPARATOR | TAK-020 placebo-matching solution, orally, once on Day 1. |
| Part 1 Cohort 1: TAK-020 0.1 mg | EXPERIMENTAL | TAK-020 0.1 mg, solution, orally once on Day 1. |
| Part 1 Cohort 2: TAK-020 0.5 mg | EXPERIMENTAL | TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1. |
| Part 1 Cohort 3: TAK-020 2.5 mg | EXPERIMENTAL | TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2. |
| Part 1 Cohort 4: TAK-020 4.4 mg | EXPERIMENTAL | TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3. |
| Part 1 Cohort 5: TAK-020 8.8 mg | EXPERIMENTAL | TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4. |
| Part 1 Cohort 6: TAK-020 17.5 mg | EXPERIMENTAL | TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5. |
| Part 1 Cohort 7: TAK-020 35 mg | EXPERIMENTAL | TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 6. |
| Part 1 Cohort 8: TAK-020 70 mg | EXPERIMENTAL | TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 7. |
| Part 1 Cohort 9: TAK-020 105 mg | EXPERIMENTAL | TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 8. |
| Part 2 Cohort 1-6: Placebo | PLACEBO_COMPARATOR | TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9. |
| Part 2 Cohort 1: TAK-020 3.75 mg | EXPERIMENTAL | TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study. |
| Part 2 Cohort 2: TAK-020 5.75 mg | EXPERIMENTAL | TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2. |
| Part 2 Cohort 3: TAK-020 13 mg | EXPERIMENTAL | TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2. |
| Part 2 Cohort 4: TAK-020 25 mg | EXPERIMENTAL | TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2. |
| Part 2 Cohort 5: TAK-020 45 mg | EXPERIMENTAL | TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2. |
| Part 2 Cohort 6: TAK-020 60 mg | EXPERIMENTAL | TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2. |
| Name | Type | Description |
|---|---|---|
| TAK-020 | DRUG | TAK-020 oral solution |
| TAK-020 Placebo | DRUG | TAK-020 placebo-matching oral solution |
Inclusion Criteria Participant eligibility is determined according to the following criteria prior to entry into the study: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. Participant or, when applicable, the participa...
TAK-020 is an investigational small molecule being developed by Takeda Pharmaceutical Company Limited. It is currently in Phase 1 clinical development, studied in healthy volunteers. The drug is not approved and remains under clinical investigation.
TAK-020 is being studied for use in healthy volunteers, as part of early-phase clinical trials to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics. It is not approved for any disease or condition and is in Phase 1 development.
TAK-020 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.
TAK-020 is in Phase 1 clinical development. A completed Phase 1 trial assessed ascending single and multiple doses of the drug in healthy volunteers. It is an investigational drug and has not been approved by regulatory authorities.
TAK-020 has one completed Phase 1 trial, NCT02413255, titled "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers." The trial enrolled 120 participants in the United States and was placebo-controlled, randomized, and double-blind.