ICON Early Phase Services, LLC
San Antonio, Texas, 78209, United States
NCT Number: NCT05247970
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
San Antonio, Texas, 78209, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Capsule administered orally
Syrup administered orally
Matching capsule to S-309309 administered orally
Time frame: Up to Day 28
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Time frame: Baseline, Day 2, 5, 7 and 16
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7 and 16
Time frame: Baseline, Day 2, 5, 7 and 16
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7 and 16
Time frame: Baseline up to Day 16
Time frame: Baseline up to Day 16
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Time frame: Up to Day 28
Shionogi
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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