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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
25
TAK-020 solution.
TAK-020 co-crystal tablet
TAK-020 Solid dispersion tablet.
Unnamed facility
Nottingham, United Kingdom
Cmax: Maximum Observed Plasma Concentration for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE)
Time frame: Baseline up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose
Time frame: Baseline up to Day 2
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time frame: Baseline up to Day 2
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
Time frame: Baseline up to Day 2
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TAK-020 immediate release tablet.
TAK-020 co-crystal tablet.
TAK-020 solid formulation