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

Completed · Phase 1 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID: NCT04838639
Run by: Otsuka Pharmaceutical Factory, Inc.
People needed: 84
Starts: 2021-06-14
Expected to finish: 2022-03-31
Last updated by the study team: 2023-11-02

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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