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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 baseline, day 2, 3, 4, 5, 6, 7 and 16
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and tolerated in healthy adults, as well as its effects on the heart.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 2, 3, 4, 5, 6, 7 and 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 2, 3, 4, 5, 6, 7 and 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 and 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Secondary outcome measures
Part 1: Apparent Total Clearance (CL/F) of S-309309
Part 1: Apparent Volume of Distribution (Vz/F) of S-309309
Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of S-309309
+22 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: S-309309 and MidazolamExperimental Treatment2 Interventions
Participants will receive S-309309 and Midazolam at specific timepoints fed state.
Group II: Part 1: S-309309Experimental Treatment1 Intervention
Participants will receive S-309309 at specific timepoints in a fasted state.
Group III: Part 1 and 2: PlaceboPlacebo Group1 Intervention
Participants will receive a matching placebo to S-309309 at specific timepoints in either a fed or fasted state.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
FDA approved
S-309309
2022
Completed Phase 1
~80
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ShionogiLead Sponsor
116 Previous Clinical Trials
41,412 Total Patients Enrolled
6 Trials studying Obesity
3,197 Patients Enrolled for Obesity
Frequently Asked Questions
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