Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 When Administered Orally to Healthy and Obese Adult Subjects

Conditions
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Obesity

Intervention / Treatment
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* Drug: NO-13065
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age Continuous non-smoker Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ECGs. Women of non-childbearing potential only Able to understand and sign a written informed consent form prior to initiation of study procedures. Exclusion Criteria: Subject is mentally or legally incapacitated or has significant emotional problems History or presence of clinically significant medical or psychiatric condition or disease History or presence : Familial hyperlipidemia, Diabetes, Bleeding disorder(s), including relevant familial history, Thromboembolic disease, Bleeding in the gastrointestinal tract or CNS, Hepatobillary disease, Gilbert's syndrome History or presence of alcohol or drug abuse. Has liver function test(s) including ALT, AST, GGT, and/or ALP or total bilirubin that are > ULN at screening or check-in. Positive urine drug or alcohol results.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NO-13065, oral tablet<br> | Drug: NO-13065<br>* 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.<br>|
| Placebo Comparator: Placebo matched to NO-13065, oral tablet<br> | Drug: Placebo<br>* Two subjects per cohort will take a matched placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) | To assess Cmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects. | 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. | 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. | 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. | 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. | Up to 29 days |