Approval Probability
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Adjusted LOA
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TAK-385 T2 Formulation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1: T2-A + T4B-B + T4B-C | EXPERIMENTAL | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose. |
| Arm 2: T2-A + T4C-D + T4C-E | EXPERIMENTAL | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose. |
| Name | Type | Description |
|---|---|---|
| TAK-385 T2 Formulation | DRUG | TAK-385 T2 Formulation tablets |
| TAK-385 T4 Formulation B | DRUG | TAK-385 T4 Formulation B tablets |
| TAK-385 T4 Formulation C | DRUG | TAK-385 T4 Formulation C tablets |
Inclusion Criteria: 1. Age 18 to 55 years, inclusive, at the time of consent. 2. Healthy adult male, as determined by a physician evaluation that includes: * Medical history (ie, no clinically significant medical conditions requiring ongoing drug therapy). * Physical examination. * Vital ...
TAK-385 T2 Formulation is an investigational small molecule developed by Takeda Pharmaceutical Company Limited. It is a tablet formulation studied in healthy adult male volunteers. The specific therapeutic indication for this formulation has not been disclosed, and it remains in clinical development rather than being an approved medicine.
TAK-385 T2 Formulation is made by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the developer responsible for the clinical program evaluating this tablet formulation. The company conducted the bioavailability and food effect study in healthy participants in the United States.
TAK-385 T2 Formulation is in Phase 1 clinical development. Its single recorded trial, NCT02396147, was a Phase 1 study that has been completed. The drug is investigational and is not an approved product; the Phase 1 work focused on bioavailability and the effect of food on the tablet formulations.
TAK-385 T2 Formulation has been studied in one clinical trial, NCT02396147, titled Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants. That Phase 1 trial was completed, enrolled 54 participants, was randomized and controlled, and took place in the United States with healthy male volunteers aged 18 years and older.
The TAK-385 T2 Formulation trial NCT02396147 was a Phase 1 bioavailability and food effect study in healthy participants. It enrolled 54 volunteers, used a randomized and controlled design, and was not double blind. Participants were healthy males aged 18 years and older, and the study was conducted in the United States. The trial has been completed.