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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: NO-13065; Drug: Placebo

• Registration Number: NCT04838639
• Lead Sponsor: Otsuka Pharmaceutical Factory, Inc.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-09
• Study Start: 2021-06-14
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NO-13065, oral tablet	NO-13065	-
Placebo matched to NO-13065, oral tablet	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States