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The primary purpose of this study is to determine the effect of repeated administration of itraconazole on the pharmacokinetic (PK) profile of S-309309; and the PK of S-309309 following administration of S-309309 alone and co-administration with itraconazole
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-309309 | Experimental | All participants will receive each of the following treatments:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S309309 | Drug | Administered as oral capsules |
| |
| Itraconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Administration of S-309309 | Up to 2 weeks postdose on Days 1, 19 | |
| Area Under the Concentration-Time Curve Extrapolated From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) After Administration of S-309309 | Up to 2 weeks postdose on Days 1, 19 | |
| Maximum Observed Plasma Concentration (Cmax) After Administration of S-309309 | Up to 2 weeks postdose on Days 1, 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 5 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc. | Dallas | Texas | 75247 | United States |
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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 |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Administered as oral capsules |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010879 |
| Piperazines |