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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: S-309309 | Experimental | Participants will receive S-309309 at specific timepoints in a fasted state. |
|
| Part 2: S-309309 and Midazolam | Experimental | Participants will receive S-309309 and Midazolam at specific timepoints fed state. |
|
| Part 1 and 2: Placebo | Placebo Comparator | Participants will receive a matching placebo to S-309309 at specific timepoints in either a fed or fasted state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-309309 | Drug | Capsule administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Plasma Concentration (Cmax) of S-309309 | 0 (predose) up to 144 hours postdose on Day 1 to Day 21 | |
| Part 1: Time to Maximum Plasma Concentration (Tmax) of S-309309 | 0 (predose) up to 144 hours postdose on Day 1 to Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39832041 | Derived | Ishibashi T, Tanioka H, Ikehara T, Kezbor S, Sonoyama T. Safety, Tolerability, and Pharmacokinetics of a Novel Anti-obesity Agent, S-309309, in Healthy Adults with or Without Obesity. Clin Drug Investig. 2025 Feb;45(2):85-99. doi: 10.1007/s40261-024-01418-3. Epub 2025 Jan 20. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | Syrup administered orally |
|
| Placebo | Drug | Matching capsule to S-309309 administered orally |
|
| Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of S-309309 | 0 (predose) up to 144 hours postdose on Day 1 to Day 21 |
| Part 1: Terminal Elimination Half-Life (t1/2,z) of S-309309 | 0 (predose) up to 144 hours postdose on Day 1 to Day 21 |
| Part 1: Terminal Elimination Rate Constant (λz) of S-309309 | 0 (predose) up to 144 hours postdose on Day 1 to Day 21 |
| Part 1: Mean Residence Time (MRT) of S-309309 | 0 (predose) up to 144 hours postdose on Day 1 to Day 21 |
| Part 1: Apparent Total Clearance (CL/F) of S-309309 | 0 (predose) up to 144 hours postdose on Day 1 to Day 21 |
| Part 1: Apparent Volume of Distribution (Vz/F) of S-309309 | 0 (predose) up to 144 hours postdose on Day 1 to Day 21 |
| Part 1: Renal Clearance (CLR) of S-309309 | 0 (predose) up to 144 hours postdose on Day 1 to Day 21 |
| Part 1: Fraction of Dose Excreted in Urine (Feu) of S-309309 | 0 (predose) up to 144 hours postdose on Day 1 to Day 21 |
| Part 1: Change From Baseline of Electrocardiogram (ECG) Parameters: QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), Pulse Rate (PR) Interval, and Combination of the Q, R, and S Waves (QRS) Duration | Baseline, Day 2, 5, 7 and 16 |
| Part 1: Change From Baseline of ECG Parameter: Heart Rate (HR) | Baseline, Day 2, 3, 4, 5, 6, 7 and 16 |
| Part 1: Placebo-Corrected Change From Baseline of ECG Parameters: QTcF, PR Interval, and QRS Duration | Baseline, Day 2, 5, 7 and 16 |
| Part 1: Placebo-Corrected Change From Baseline of ECG Parameter: HR | Baseline, Day 2, 3, 4, 5, 6, 7 and 16 |
| Part 1: Number of Participants With Categorical Outlier Values for HR, QTcF, PR, and QRS | Baseline up to Day 16 |
| Part 1: Number of Participants With Treatment-Emergent Changes for T-wave Morphology and Presence of U-wave | Baseline up to Day 16 |
| Part 2: Cmax of S-309309 and Midazolam | 0 (predose) up to 24 hours postdose on Day -2 to Day 16 |
| Part 2: Tmax of S-309309 and Midazolam | 0 (predose) up to 24 hours postdose on Day -2 to Day 16 |
| Part 2: AUC of S-309309 and Midazolam | 0 (predose) up to 24 hours postdose on Day -2 to Day 16 |
| Part 2: t1/2,z of S-309309 and Midazolam | 0 (predose) up to 24 hours postdose on Day -2 to Day 16 |
| Part 2: λz of S-309309 and Midazolam | 0 (predose) up to 24 hours postdose on Day -2 to Day 16 |
| Part 2: CL/F of S-309309 and Midazolam | 0 (predose) up to 24 hours postdose on Day -2 to Day 16 |
| Part 2: Vz/F of S-309309 and Midazolam | 0 (predose) up to 24 hours postdose on Day -2 to Day 16 |
| Part 2: MRT of Midazolam | 0 (predose) up to 24 hours postdose on Day -2 to Day 16 |
| Part 2: Number of Participants with TEAEs After Coadministration with Midazolam | Up to Day 28 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |