Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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