Clinical trial NCT02723201
Conditions: Healthy
Sponsor: Takeda
Start date: 2016-04-28; Completion date: 2016-08-24
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: 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. arm 2: 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. arm 3: 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. arm 4: 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. arm 5: 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. arm 6: Single oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2 arm 7: Single oral dose on Day 1. Dose will be determined from SRD trial and Parts 1 and 2
Interventions: intervention 1: TAK-020 Captisol Oral Solution intervention 2: TAK-020 CCT intervention 3: TAK-020 SDT intervention 4: TAK-020 IRT intervention 5: TAK-020 CCT intervention 6: TAK-020 Solid Formulation
Intervention descriptions: intervention 1: TAK-020 solution. intervention 2: TAK-020 co-crystal tablet intervention 3: TAK-020 Solid dispersion tablet. intervention 4: TAK-020 immediate release tablet. intervention 5: TAK-020 co-crystal tablet. intervention 6: TAK-020 solid formulation

Protocol documents: