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

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)

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