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)

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics in Obese Adolescents
• Intervention / Treatment: Drug: Lorcaserin

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 Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Texas
    • San Antonio, Texas, United States, 78217
      • Worlwide Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Open-Label Lorcaserin (BELVIQ)	Drug: Lorcaserin; Other Names: BELVIQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (ESTIMATE): December 30, 2013

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: APD356-025