Clinical trial NCT02022956: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics in Obese Adolescents
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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)

Eligibility 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

Primary outcomes:
measure: Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: San Antonio
country: United States
facility: Worlwide Clinical Trials
state: Texas
Study officials:
References: