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Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg dose of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lorcaserin 10 mg | Experimental | Cohort 1 - obese pediatric participants between age group of 6 and 8 years (inclusive) Cohort 2 - obese pediatric participants between age group of 9 and 11 years (inclusive) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin hydrochloride | Drug | A single 10 mg dose of oral tablet formulation of lorcaserin hydrochloride will be administered with 240 mL of water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK profile of lorcaserin and its primary metabolites (M1 and M5) | Day 1 at 1, 2, 3, 4, and 6 hours postdose, Day 2 (24 +/- 2 h postdose), Day 3 (48 +/- 2 h postdose), and Day 5 (96 +/- 2 h postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) / Serious Adverse Events (SAEs) as a measure of safety and tolerabilty | Safety will be assessed by monitoring and recording all AEs and SAEs, monitoring hematology, blood chemistry and urine values, measuring vital signs and ECG, and the performing physical examinations. | From signing of informed consent until 30 days from participant's last dose or until resolution |
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Inclusion Criteria:
Males and females aged 6 years to 11 years (up to 11 years and 364 days), inclusive, at Screening.
BMI greater than or equal to 99th percentile for age and gender as defined as:
Age Boys Girls 6 21.6 23.0 7 23.6 24.6 8 25.6 26.4 9 27.6 28.2 10 29.3 29.9 11 30.7 31.5
but less than or equal to 44kg/m2 at Screening.
Provide written informed consent signed by parent/legal guardian prior to entering the study or undergoing any study procedures. A written or verbal assent from the subjects will also be obtained.
Females aged at least 8 years should have a negative serum B-human chorionic gonadotropin (beta-hCG) at Visit 1 and a negative urine pregnancy test prior to receiving their first dose of study drug at Visit 2.
Willing and able to comply with all aspects of the protocol.
Able to swallow a single tablet.
Exclusion Criteria:
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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 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |