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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838639
• Other study ID #: 360-101
• Status: Completed
• Phase: Phase 1
• Start date: June 14, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Otsuka Pharmaceutical Factory, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age

2. Continuous non-smoker

3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ECGs.

4. Women of non-childbearing potential only

5. Able to understand and sign a written informed consent form prior to initiation of study procedures.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated or has significant emotional problems

2. History or presence of clinically significant medical or psychiatric condition or disease

3. 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

4. History or presence of alcohol or drug abuse.

5. Has liver function test(s) including ALT, AST, GGT, and/or ALP or total bilirubin that are > ULN at screening or check-in.

6. Positive urine drug or alcohol results.

Related Conditions & MeSH terms

• Obesity

Intervention

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
Two subjects per cohort will take a matched placebo.

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Factory, Inc.	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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