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A Phase 1 Randomized, Double-blind, Single and Multiple-dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of S-309309 in Healthy and Obese Adult Study Participants
The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. The secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on ECG parameters after oral administration in healthy or obese but otherwise healthy participants.
This study will consist of 2 Parts. Part 1 will include healthy participants who will be assigned to a dose group. Participants will then be randomized to receive a single oral administration of S-309309 or placebo in a fasted state. Administration will be initiated in the lowest dose group, and administration in the next dose group will not occur until a review of safety and tolerability has been completed for the preceding group. Part 2 will include 2 groups. Healthy participants and obese but otherwise healthy participants will receive multiple oral administrations of S-309309 or placebo in a fed state.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
ICON Early Phase Services, LLC
San Antonio, Texas, United States
Start Date
January 4, 2022
Primary Completion Date
October 20, 2022
Completion Date
November 1, 2022
Last Updated
January 11, 2023
74
ACTUAL participants
S-309309
DRUG
Midazolam
DRUG
Placebo
DRUG
Lead Sponsor
Shionogi
NCT01143454
NCT07472881
Data Source & Attribution
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