Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT02398669
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2015-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Dose Pharmacokinetic Study of Lorcaserin Hydrochloride in Obese Pediatric Subjects 6 to 11 Years of Age
Sponsor:
Eisai Inc.
Organization:
Study Overview
Official Title:
An Open-Label, Single Dose Study to Assess Pharmacokinetics, Safety and Tolerability of Lorcaserin Hydrochloride in Obese Pediatric Subjects 6 to 11 Years of Age
Status:
COMPLETED
Status Verified Date:
2015-11
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:
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.
Detailed Description:
None
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?: