This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Single ascending doses of NO-13065 in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065. Single ascending dose of NO-13065 with food effect arm. Multiple ascending doses of NO-13065 for 10 or up to 28 days in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065.
Two subjects per cohort will take a matched placebo.
Celerion
Lincoln, Nebraska, United States
The number and severity of treatment emergent adverse events (TEAEs)
To assess the safety and tolerability of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Time frame: Up to 35 days
Maximum plasma concentration (Cmax)
To assess Cmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Time frame: Up to 35 days
Area under the plasma concentration-time curve (AUC)
To assess AUC of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Time frame: Up to 35 days
Time to reach Cmax (Tmax)
To assess Tmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Time frame: Up to 35 days
Apparent first-order terminal elimination half-life (t ½)
To assess t ½ of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Time frame: Up to 35 days
Correlation between QTc and NO-13065 plasma concentrations
To explore the correlation between changes in QTc interval (msec) and NO-13065 plasma concentrations, appropriate correction method for QTc interval calculation such as QTcF will used for analysis.
Time frame: Up to 29 days
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