NCT02022956

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

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

The purpose is to: 1. Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive) 2. Assess the safety and tolerability of a single oral dose of lorcaserin in obese adolescent subjects ages 12-17 (inclusive)

Conditions

• Pharmacokinetics in Obese Adolescents

Interventions

Type	Name	Description
DRUG	Lorcaserin

Timeline

• Start date: 2013-12-01
• Primary completion: 2013-12-01
• First posted: 2013-12-30
• Last updated: 2019-09-17

Locations

2 sites across 1 country: United States