A Single Dose Pharmacokinetic Study of Lorcaserin Hydrochloride in Obese Pediatric Subjects 6 to 11 Years of Age

NCT02398669 | Completed Phase 1

• 1 other identifier: APD356-A001-026
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg dose of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age.

Conditions

Obesity

Keywords

Obesity; Lorcaserin hydrochloride; APD356; Pediatric; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Plasma PK profile of lorcaserin and its primary metabolites (M1 and M5)

  Day 1 at 1, 2, 3, 4, and 6 hours postdose, Day 2 (24 +/- 2 h postdose), Day 3 (48 +/- 2 h postdose), and Day 5 (96 +/- 2 h postdose)

Secondary Outcomes (1)

• Number of participants with Adverse Events (AEs) / Serious Adverse Events (SAEs) as a measure of safety and tolerabilty

  From signing of informed consent until 30 days from participant's last dose or until resolution

Study Arms (1)

lorcaserin 10 mg

EXPERIMENTAL

Cohort 1 - obese pediatric participants between age group of 6 and 8 years (inclusive) Cohort 2 - obese pediatric participants between age group of 9 and 11 years (inclusive)

Drug: Lorcaserin hydrochloride

Interventions

Lorcaserin hydrochloride DRUG

A single 10 mg dose of oral tablet formulation of lorcaserin hydrochloride will be administered with 240 mL of water.

Also known as: APD356

lorcaserin 10 mg

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females aged 6 years to 11 years (up to 11 years and 364 days), inclusive, at Screening.
• BMI greater than or equal to 99th percentile for age and gender as defined as:
• Age Boys Girls 6 21.6 23.0 7 23.6 24.6 8 25.6 26.4 9 27.6 28.2 10 29.3 29.9 11 30.7 31.5
• but less than or equal to 44kg/m2 at Screening.
• Provide written informed consent signed by parent/legal guardian prior to entering the study or undergoing any study procedures. A written or verbal assent from the subjects will also be obtained.
• Females aged at least 8 years should have a negative serum B-human chorionic gonadotropin (beta-hCG) at Visit 1 and a negative urine pregnancy test prior to receiving their first dose of study drug at Visit 2.
• Willing and able to comply with all aspects of the protocol.
• Able to swallow a single tablet.

You may not qualify if:

• Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing
• Evidence of disease that may influence the outcome of the study within 4 weeks of dosing (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or subjects who have a congenital abnormality in metabolism)
• Secondary (chromosomal, endocrine, or metabolic) causes of obesity (eg, Prader-Willi syndrome, Down's Syndrome, untreated hypothyroidism, or Cushing's syndrome).
• Any history of abdominal surgery that may affect PK evaluations (eg, hepatectomy, nephrotomy, digestive organ resection or any gastrointestinal procedure for the purpose of weight loss, which would slow gastric emptying).
• Any clinically relevant symptom or organ impairment found by medical history, physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening.
• Special needs subjects who are unable to comprehend trial-related instructions (eg, mild to profound mental retardation, moderate to severe cognitive developmental delay, pervasive developmental disorders, autism).
• Females who are sexually active.
• Ongoing epilepsy or other seizure disorder, or use of medications for a seizure disorder within 6 months of the Screening or between Screening and Day 1.
• History of congestive heart failure, pulmonary arterial hypertension, congenital heart disease, or organ transplantation.
• Resting heart rate less than 50 or greater than 120 beats/min at Screening or predose on Day 1.
• Systolic blood pressure (BP) greater than 140 mmHg or less than 90 mmHg or diastolic blood pressure greater than 90 mmHg or less than 60 mmHg at Screening or predose on Day 1.
• Hypersensitivity to the study drug or any of its excipients.
• Significant change in diet or level of physical activity within 1 month prior to dosing or change in weight of greater than 5 kg within 3 months prior to dosing.
• Known to be human immunodeficiency virus (HIV) positive at Screening.
• Active viral hepatitis (B or C) as demonstrated by positive serology at Screening.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 25, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

US (1)