Clinical trial NCT02714062: A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
Official title: A Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study of VI-0521 in Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pediatric Obesity
Childhood Obesity
Keywords: Adolescent Obesity
Childhood Obesity
Qsymia
Pharmacokinetics
VI-0521
Phentermine
Topiramate
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2016-03-21
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent;
* Provide written assent (of study subject);
* Adolescent ≥12 and \<18 years of age;
* Have a BMI ≥ the 95th percentile of BMI for age and gender;
* Female subjects must be using adequate contraception;
* Willing and able to comply with all study requirements

Exclusion Criteria:

* Condition or disease interfering with metabolism;
* Any medical treatment with insulin;
* Hyperthyroidism, or clinically significant hypothyroidism;
* Any history of bipolar disorder or psychosis, major depressive disorder, or history of suicidal behavior or ideation, or any use of antidepressant medications;
* Use of chronic systemic glucocorticoid or steroid therapy;
* History of any eating disorders;
* Any history of laxative abuse;
* Prior bariatric surgery;
* Any history of nephrolithiasis;
* Any history of epilepsy, or treatment with anti-seizure medications;
* Positive urine drug screen;
* Current smoker or smoking cessation within the previous 3 months of screening;
* Obesity of a known genetic or endocrine origin;
* Treatment with any over-the-counter or prescription weight loss drug, or attention-deficit/hyperactivity disorder (ADHD);
* Allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to any drug;
* Use of any investigational medication or device for any indication or participation in a clinical study within 30 days prior to screening; or
* Any medical or surgical condition which would impair the ability of the subject to complete the study, compromise the quality of study data, or pose an unacceptable risk to the safety of the subject.

Primary outcomes:
measure: Apparent Clearance (CL/F) of Phentermine and Topiramate
timeFrame: On Days 14, 28, 42, and 56
measure: Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
timeFrame: On Days 14, 28, 42, and 56
measure: Area Under the Curve (AUC) of Phentermine
timeFrame: On Days 14, 28, 42, and 56
measure: Maximum Concentration (Cmax) of Phentermine
timeFrame: On Days 14, 28, 42, and 56
measure: Area Under the Curve (AUC) of Topiramate
timeFrame: On Days 14, 28, 42, and 56
measure: Maximum Concentration (Cmax) of Topiramate
timeFrame: On Days 14, 28, 42, and 56
Secondary outcomes:
measure: Weight Loss
timeFrame: 56 days
measure: Change in Waist Circumference
timeFrame: 56 days
measure: Change in Blood Pressure
timeFrame: 56 days
measure: Change in OGTT of Fasting and 2-hour Glucose
timeFrame: 56 days
measure: Change in Lipid Parameters
timeFrame: 56 days
measure: Change in Visual Analog Scale (VAS) Hunger Scores
timeFrame: 56 days
measure: Change in Visual Analog Scale (VAS) Satiety Scores
timeFrame: 56 days
measure: Change in HOMA-IR
timeFrame: 56 days
measure: Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)
timeFrame: 56 days
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Research Facility
state: Louisiana
city: Marrero
country: United States
facility: Research Facility
state: Louisiana
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Charleston
country: United States
facility: Research Facility
state: South Carolina
Study officials:
affiliation: Pennington Biomedical Research
name: Daniel Hsia, M.D.
role: PRINCIPAL_INVESTIGATOR
References: