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The primary objective of this study is to evaluate the effect of a meal and evening dosing on the pharmacokinetics (PK) of KAI 7535 in healthy participants living with obesity or overweight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KAI-7535: Morning Dosing, Fed | Experimental | Participants will receive KAI-7535 in the morning following a meal on dosing days. |
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| KAI-7535: Morning Dosing, Fasted | Experimental | Participants will receive KAI-7535 in the morning following an overnight fast on dosing days. |
|
| KAI-7535: Evening Dosing | Experimental | Participants will receive KAI-7535 in the evening on dosing days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAI-7535 | Drug | Oral tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Observed Concentration (Tmax) of KAI-7535 | Pre-dose and up to 60 hours post-dose | |
| Maximum Observed Concentration (Cmax) of KAI-7535 | Pre-dose and up to 60 hours post-dose | |
| Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-7535 | Pre-dose and up to 60 hours post-dose | |
| Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-7535 | Pre-dose and up to 60 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with a Treatment-emergent Adverse Event (TEAE) | Day 1 up to Day 12 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |