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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02022956
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Pharmacokinetics in Obese Adolescents Drug: Lorcaserin 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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
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 : December 2013
Actual Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lorcaserin

Arm Intervention/treatment
Experimental: Open-Label Lorcaserin (BELVIQ) Drug: Lorcaserin
Other Name: BELVIQ




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) [ Time Frame: 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 ]


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022956


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Worlwide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Eisai Inc.

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02022956    
Other Study ID Numbers: APD356-025
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: March 2014
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms