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Completed

NCT Number: NCT04838639

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NO-13065

Drug

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

Drug

Two subjects per cohort will take a matched placebo.

Primary outcomes

  1. The number and severity of treatment emergent adverse events (TEAEs)

    Time frame: 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 outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Up to 35 days

    To assess Cmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.

  2. Area under the plasma concentration-time curve (AUC)

    Time frame: Up to 35 days

    To assess AUC of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.

  3. Time to reach Cmax (Tmax)

    Time frame: Up to 35 days

    To assess Tmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.

  4. Apparent first-order terminal elimination half-life (t ½)

    Time frame: 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.

  5. Correlation between QTc and NO-13065 plasma concentrations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Factory, Inc.

Industry

Collaborators

  • Celerion

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2021
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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