Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the PK properties, tolerability, and safety of lorcaserin HCL (BELVIQ) in obese adolescent subjects between the ages of 12 to 17 years old
The purpose is to:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label Lorcaserin (BELVIQ) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive) | 45 min pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose |
Not provided
Not provided
Inclusion Criteria:
Adolescent subjects aged 12 to 17 years, inclusive at screening
a. Eligible female subjects who are sexually active will be:
BMI ≥ 95th percentile for age and gender, but ≤ 44 kg/m21
Considered to be in stable health in the opinion of the Investigator.
Parent or guardian who can sign written informed consent and subject willing to sign assent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States | ||
| Worlwide Clinical Trials |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| San Antonio |
| Texas |
| 78217 |
| United States |
| ID | Term |
|---|---|
| C506658 | lorcaserin |
Not provided
Not provided
Not provided