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

Phase 1

Completed

• Conditions: Pharmacokinetics in Obese Adolescents
• Interventions: Drug: Lorcaserin

• Registration Number: NCT02022956
• Lead Sponsor: Eisai Inc.

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)

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2013-12
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Status Verified: 2014-03
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Adolescent subjects aged 12 to 17 years, inclusive at screening

2. a. Eligible female subjects who are sexually active will be:

   • non-pregnant
   • non-lactating
   • agree to continue to use an accepted method of birth control for at least 1 month after study medication administration

3. BMI ≥ 95th percentile for age and gender, but ≤ 44 kg/m21

4. Considered to be in stable health in the opinion of the Investigator.

5. Parent or guardian who can sign written informed consent and subject willing to sign assent

Exclusion Criteria

1. Clinically significant new illness in the 1 month before screening and any time prior to randomization
2. Significant renal or hepatic disease
3. Secondary (chromosomal, endocrine, or metabolic) causes of obesity
4. Use of medications other than hormonal contraceptives and acetaminophen
5. Use of drugs with serotonergic activity within 1 month before screening
6. 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
7. Recent history of alcohol, tobacco, or recreational drug/solvent use
8. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-Label Lorcaserin (BELVIQ)	Lorcaserin	-

Primary Outcome Measures

Name	Time	Method
Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive)	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

Trial Locations

Locations (2)

Worlwide Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States