Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-020 Captisol · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part-1, Period 1: TAK-020 17.5 mg Oral Solution | EXPERIMENTAL | Single dose 17.5 milligram (mg), on Day 1, followed by 7 days of washout. Dose will be determined from TAK-020 single rising dose (SRD) trial. |
| Part-1, Period 2: TAK-020 17.5 mg Co-crystal Tablet (CCT) | EXPERIMENTAL | Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. |
| Part-1, Period 3:TAK-020 17.5 mg Solid Dispersion Tablet (SDT) | EXPERIMENTAL | Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. |
| Part-1, Period 4:TAK-020 17.5 mg Immediate Release Tablet(IRT) | EXPERIMENTAL | Single oral dose 17.5 mg, on Day 1, followed by 7 days of washout. Dose will be the same as Part 1, Period 1. |
| Part 2, Period 1: TAK-020 25 mg CCT | EXPERIMENTAL | Participants will be randomized to AB or BA crossover where A= Fasted, B =Fed. Sequence I: Single oral dose TAK-020 25 mg, Fasted (A), 7 days washout, single oral dose TAK-020 Fed (B) Sequence II: Single oral dose TAK-020 25 mg, Fed (B), 7 days washout, single oral dose TAK-020 Fasted (A) Dose will be determined from SRD trial and Part 1. |
| Part- 3 Cohort 1: TAK-020 Solid Formulation | EXPERIMENTAL | Single oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2 |
| Part 3 Cohort 2: TAK-020 Solid Formulation | EXPERIMENTAL | Single oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2 |
| Name | Type | Description |
|---|---|---|
| TAK-020 Captisol Oral Solution | DRUG | TAK-020 solution. |
| TAK-020 CCT | DRUG | TAK-020 co-crystal tablet |
| TAK-020 SDT | DRUG | TAK-020 Solid dispersion tablet. |
| TAK-020 IRT | DRUG | TAK-020 immediate release tablet. |
| TAK-020 Solid Formulation | DRUG | TAK-020 solid formulation |
Inclusion Criteria: 1. Is capable of understanding and complying with protocol requirements. 2. Is legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a pa...
TAK-020 Captisol is an investigational small molecule being studied in healthy participants. It is not approved for any disease and is in Phase 1 clinical development. The completed trial evaluated its relative bioavailability and the effect of food on its absorption in healthy volunteers.
TAK-020 Captisol is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company conducted a Phase 1 study of the drug in healthy participants in the United Kingdom.
TAK-020 Captisol is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not currently in active clinical trials.
TAK-020 Captisol was studied in a completed Phase 1 trial with the identifier NCT02723201, titled "TAK-020 Relative Bioavailability and Food Effect Study in Healthy Participants." The trial enrolled 25 healthy participants in the United Kingdom and was a randomized, controlled study.
TAK-020 Captisol is a formulation of TAK-020 that uses Captisol, a solubilizing agent. The clinical trial NCT02723201 studied this specific formulation in healthy participants to assess its relative bioavailability and the effect of food on its absorption.