Healthy Volunteer Study to Evaluate Formulations of TAK-020 (117538)
Research type
Research Study
Full title
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.
IRAS ID
190976
Contact name
Adesegun Afuwape
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd
Eudract number
2015-002635-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 14 days
Research summary
The Sponsor is developing the study drug, TAK-020, for the potential treatment of autoimmune disease. In autoimmune disease the immune system, which normally fights infection, attacks healthy cells. TAK-020 inhibits the activation of this mechanism and could treat diseases such as inflammatory bowel disease, systemic lupus erythematosus and rheumatoid arthritis.\n\nCurrently TAK-020 is given as a liquid. The Sponsor wishes to develop a tablet formulation for use in future clinical studies and in patients. 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 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.\n\nIn Part 1 subjects will receive a single dose of the following:\nPeriod 1: TAK-020 Captisol Oral Solution\nPeriod 2: TAK-020 Gentisic Acid Co-Crystal Tablet\nPeriod 3: TAK-020 Captisol Spray Dried Dispersion Tablet\nPeriod 4: TAK-020 Immediate Release Tablet\n\nIn Part 2 subjects 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.\n\nSubjects 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 the fasted evaluation in Part 1.
REC name
Wales REC 2
REC reference
16/WA/0012
Date of REC Opinion
22 Jan 2016
REC opinion
Favourable Opinion