NCT02723201

TAK-020 Relative Bioavailability and Food Effect Study in Healthy Participants

A Randomized, Open Label Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of a Single Dose of Various Test Solid Formulations of TAK-020 Compared With a Single Dose of Reference Oral Solution and to Evaluate the Food Effect and Potentially the Dose Proportionality of the Optimal Solid Dose Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the relative bioavailability of solid oral formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation and to evaluate the food effect and potentially the dose proportionality of the optimal oral solid formulation.

Detailed description

TAK-020 is being developed for the potential treatment of autoimmune diseases including rheumatoid arthritis. Currently TAK-020 is available as an oral solution. This study is to develop an oral tablet formulation. There are three parts to this study. Part 1 will compare different tablet formulations of TAK-020 compared to a reference oral solution to identify the best tablet formulation to use in Parts 2 and 3. Part 2 will look at the effect food has on TAK-020. Part 3 is optional; its implementation will be decided upon using data from Part 2. It will evaluate whether increased doses of TAK-020 produce an expected proportional increase in the plasma concentration of TAK-020. In Part 1 participants will receive a single dose of the following: Period 1: TAK-020 Oral Solution Period 2: TAK-020 Co-Crystal Tablet Period 3: TAK-020 Solid Dispersion Tablet Period 4: TAK-020 Immediate Release Tablet In Part 2 participants will be split into two groups; one will receive the chosen formulation of TAK-020 in the fasted state followed by the fed state and the other group will receive it in the fed state followed by the fasted state. The dose used in Part 2 will be based upon data from Part 1 and previous studies. Participants in Part 3 of the study will be split into 2 cohorts. Each cohort will be administered, in the fasted state, a single dose of the tablet selected as optimal from previous study parts. The dose used will be based upon data from Parts 1 and 2 and previous studies. Part 1 will assess the relative bioavailability of TAK-020 by using analysis of variance (ANOVA) on tmax, and the natural logarithms of AUCs, and Cmax. Part 2 will assess the food effect of TAK-020, also using ANOVA on tmax, and the natural logarithms of AUCs, and Cmax. The power model will be used to assess dose proportionality of single doses of the solid formulations in the fasted state from Parts 2 and 3.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TAK-020 Captisol Oral Solution	TAK-020 solution.
DRUG	TAK-020 CCT	TAK-020 co-crystal tablet
DRUG	TAK-020 SDT	TAK-020 Solid dispersion tablet.
DRUG	TAK-020 IRT	TAK-020 immediate release tablet.
DRUG	TAK-020 CCT	TAK-020 co-crystal tablet.
DRUG	TAK-020 Solid Formulation	TAK-020 solid formulation

Timeline

• Start date: 2016-04-28
• Primary completion: 2016-08-05
• Completion: 2016-08-24
• First posted: 2016-03-30
• Last updated: 2018-04-13
• Results posted: 2018-04-13

Locations

1 site across 1 country: United Kingdom