Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-01 @ 8:23 AM
Study NCT ID:
NCT02022956
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2013-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Eisai Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: