Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects
Lead Sponsor:
Otsuka Pharmaceutical Factory, Inc.
Collaborating Sponsors:
Celerion
Conditions:
Obesity
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
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 N...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04838639
Start Date
June 14 2021
End Date
March 31 2022
Last Update
November 2 2023
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502