Phase 1 PK study in healthy adult subjects (QCL118137)
Research type
Research Study
Full title
Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Intraoral Formulations of ZGN-1061 in Healthy Adult Subjects
IRAS ID
236503
Contact name
Karin Zeh
Contact email
Sponsor organisation
Zafgen Inc.
Eudract number
2017-004170-34
Duration of Study in the UK
0 years, 1 months, 20 days
Research summary
Zafgen Inc (the sponsor) is developing the test medicine ZGN-1061. ZGN-1061 may eventually be used for the treatment of obesity, type 2 diabetes, and/or other metabolic diseases. Metabolic diseases occur when abnormal chemical reactions in the body affect how the body gets energy from food.\n\nThe purpose of this study is to test different formulations (recipes) to better understand how ZGN-1061 is taken up by the body when dosed as new formulations. We will also look at the safety and tolerability of ZGN-1061.\n\nThis study consists of up to 2 parts involving up to 64 healthy male and female subjects. In Part 1, up to 32 subjects will be enrolled into 4 groups. Subjects will attend the clinical unit once to receive one dose of a ZGN-1061 formulation. Four treatment regimens (A-D) will be involved, subjects will be randomised to the regimens. In Regimens A and B subjects will receive a ZGN-1061 buccal or sublingual tablet (to be held under the tongue). Regimen C is a ZGN-1061 solution given as an injection and Regimen D will be a ZGN-1061 intraoral solution given by mouth. In Part 2, up to 32 subjects may be enrolled into 4 groups and will be dosed with possible Regimens E-H. If more than 1 regimen is dosed, subjects will be randomised to receive one of the possible regimens on one occasion. Subjects will either receive a ZGN-1061 buccal tablet, sublingual tablet or solution (to be held under the tongue) which could be a different dose, mouth position or new formulation; or a ZGN-1061 injection. This will be decided once Part 1 is complete. All subjects will be dosed on Day 1 and will be discharged from the clinical unit on Day 2. Subjects will return for a follow-up visit after approximately 7 days. \n
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0624
Date of REC Opinion
15 Dec 2017
REC opinion
Favourable Opinion