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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. (Industry)
Overall Status
Completed
CT.gov ID
NCT02022956
Collaborator
(none)
8
Enrollment
2
Locations
1
Arm
4
Patients Per Site

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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)
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open-Label Lorcaserin (BELVIQ)

Drug: Lorcaserin
Other Names:
  • BELVIQ

    		•

    Outcome Measures

    Primary Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

      1. 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

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

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

    3. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    2 Worlwide Clinical Trials San Antonio Texas United States 78217

    Sponsors and Collaborators

    • Eisai Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eisai Inc.
    ClinicalTrials.gov Identifier:
    NCT02022956
    Other Study ID Numbers:
    • APD356-025
    First Posted:
    Dec 30, 2013
    Last Update Posted:
    Sep 17, 2019
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of Sep 17, 2019