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Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects
Phase 1
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Factory, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 days
Summary
This trial tests a new drug called NO-13065 in healthy and obese adults to see if it is safe and how it behaves in the body when taken in different amounts and with food.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 35 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The number and severity of treatment emergent adverse events (TEAEs)
Secondary study objectives
Apparent first-order terminal elimination half-life (t ½)
Area under the plasma concentration-time curve (AUC)
Correlation between QTc and NO-13065 plasma concentrations
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NO-13065, oral tabletExperimental Treatment1 Intervention
Group II: Placebo matched to NO-13065, oral tabletPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NO-13065
2021
Completed Phase 1
~90
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
CelerionIndustry Sponsor
84 Previous Clinical Trials
7,846 Total Patients Enrolled
Otsuka Pharmaceutical Factory, Inc.Lead Sponsor
1 Previous Clinical Trials
13 Total Patients Enrolled
Koushi IwataStudy ChairOtsuka Pharmaceutical Factory, Inc.