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

NCT02022956 | Completed Phase 1

• 1 other identifier: APD356-025
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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

Conditions

Pharmacokinetics in Obese Adolescents

Outcome Measures

Primary Outcomes (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)

  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

Study Arms (1)

Open-Label Lorcaserin (BELVIQ)

EXPERIMENTAL

Drug: Lorcaserin

Interventions

Lorcaserin DRUG

Also known as: BELVIQ

Open-Label Lorcaserin (BELVIQ)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adolescent subjects aged 12 to 17 years, inclusive at screening
• 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
• BMI ≥ 95th percentile for age and gender, but ≤ 44 kg/m21
• Considered to be in stable health in the opinion of the Investigator.
• Parent or guardian who can sign written informed consent and subject willing to sign assent

You may not qualify if:

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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Worlwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

lorcaserin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 30, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2013
• Last Updated: September 17, 2019

Record last verified: 2014-03

Locations

US (2)