Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: NO-13065, oral tablet
|
Drug: NO-13065
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.
|
Placebo Comparator: Placebo matched to NO-13065, oral tablet
|
Drug: Placebo
Two subjects per cohort will take a matched placebo.
|
Outcome Measures
Primary Outcome Measures
- The number and severity of treatment emergent adverse events (TEAEs) [Up to 35 days]
To assess the safety and tolerability of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Secondary Outcome Measures
- Maximum plasma concentration (Cmax) [Up to 35 days]
To assess Cmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
- Area under the plasma concentration-time curve (AUC) [Up to 35 days]
To assess AUC of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
- Time to reach Cmax (Tmax) [Up to 35 days]
To assess Tmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
- Apparent first-order terminal elimination half-life (t ½) [Up to 35 days]
To assess t ½ of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
- Correlation between QTc and NO-13065 plasma concentrations [Up to 29 days]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Celerion | Lincoln | Nebraska | United States | 68502 |
Sponsors and Collaborators
- Otsuka Pharmaceutical Factory, Inc.
- Celerion
Investigators
- Study Chair: Koushi Iwata, Otsuka Pharmaceutical Factory, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 360-101