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
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Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive) [ Time Frame: 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 ]
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Layout table for eligibility information
Ages Eligible for Study:
12 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adolescent subjects aged 12 to 17 years, inclusive at screening
a. Eligible female subjects who are sexually active will be:
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
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