The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as multiple ascending oral doses over 14 days to healthy obese male volunteers.
Complexa has developed an oral formulation of CXA-10. The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as multiple ascending oral doses over 14 days to healthy obese male volunteers. The pharmacodynamic (PD) effects of CXA-10 on serum biomarkers, some of which are elevated in the obese population, will also be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid
The placebo contains olive oil with BHT (0.08% to 0.10%).
Jasper Clinical Research & Development, Inc.
Kalamazoo, Michigan, United States
Safety (adverse events) and tolerability of multiple ascending oral doses of CXA 10 administered daily for 14 days
Time frame: 14 days
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