Single Dose Study to Determine the Safety, Tolerability, and Pharmacokinetic Properties of Lorcaserin Hydrochloride (BELVIQ) in Obese Adolescents From 12 to 17 Years of Age

Study Overview
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Brief Summary
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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

Detailed Description
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The purpose is to: Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive) Assess the safety and tolerability of a single oral dose of lorcaserin in obese adolescent subjects ages 12-17 (inclusive)

Official Title
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An Open-label, Single-dose Study to Assess the Safety, Tolerability and Pharmacokinetic Properties of BELVIQ in Obese Adolescent Subjects Ages 12-17 (Inclusive)

Conditions
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Pharmacokinetics in Obese Adolescents

Intervention / Treatment
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* Drug: Lorcaserin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescent subjects aged 12 to 17 years, inclusive at screening a. Eligible female subjects who are sexually active will be: non-pregnant non-lactating agree to continue to use an accepted method of birth control for at least 1 month after study medication administration 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: Clinically significant new illness in the 1 month before screening and any time prior to randomization Significant renal or hepatic disease Secondary (chromosomal, endocrine, or metabolic) causes of obesity Use of medications other than hormonal contraceptives and acetaminophen Use of drugs with serotonergic activity within 1 month before screening Recent treatment with over-the-counter weight loss products or appetite suppressants, or within 3 months of screening and any time prior to randomization with a prescription weight loss drug or lipid dissolving injections or ongoing psychotherapy for weight loss outside of this trial Recent history of alcohol, tobacco, or recreational drug/solvent use Any history of major depression, anxiety, bipolar disorder, schizophrenia, or Axis II psychiatric disease requiring treatment with prescription medication within six months prior to screening

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-Label Lorcaserin (BELVIQ)<br> | Drug: Lorcaserin<br> <br> * Other names: BELVIQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |