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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 being studied in healthy volunteers. It is a tablet formulation of TAK-385, and the clinical trial for this formulation focuses on evaluating its bioavailability and the effect of food on the drug in healthy participants. It is not approved for any disease indication.
TAK-385 T2 Formulation is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this tablet formulation of TAK-385 in healthy volunteers.
TAK-385 T2 Formulation is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial for this formulation has been completed.
TAK-385 T2 Formulation has one completed Phase 1 clinical trial, identified as NCT02396147. The study, titled 'Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants,' enrolled 54 healthy male participants in the United States and evaluated the drug's bioavailability and the effect of food on it.
TAK-385 T2 Formulation is a specific tablet formulation of the drug TAK-385. The clinical trial NCT02396147 was designed to assess the bioavailability and food effect of TAK-385 tablet formulations, including the T2 formulation, in healthy participants.