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

Otsuka

Status and phase

Completed

Phase 1

Conditions

Obesity

Treatments

Drug: Placebo

Drug: NO-13065

Study type

Interventional

Funder types

Industry

Identifiers

NCT04838639

360-101

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.