Pharmacokinetic Study of Belviq in Adult Korean Volunteers

NCT01880502 | Completed Phase 1

• 1 other identifier: ID_Belviq_1301
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled, single-dose, dose escalation study (Phase I) to evaluate the tolerability and pharmacokinetics of Belviq in adult Korean volunteers.

Conditions

Healthy

Keywords

Healthy, Volunteers

Outcome Measures

Primary Outcomes (6)

• Vital signs

  participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days

• adverse event

  participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days

• electrocardiography

  participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days

• clinical laboratory tests

  participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days

• physical exam

  participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 day

• echocardiography

  participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days

Secondary Outcomes (3)

• Change in Belviq concentration in the blood with time

  Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication.

• Cmax, Cmax/D, AUClast, AUClast/D, AUCinf, AUCinf/D, tmax, t1/2 of Belviq

  Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication.

• CL/F, Vz/F of Belviq

  Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication

Study Arms (3)

Belviq 10mg

EXPERIMENTAL

Drug: Belviq 10mg

Belviq 20mg

EXPERIMENTAL

Drug: Belviq 20mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Belviq 10mg DRUG

Belviq 10mg single dose administration

Belviq 10mg

Belviq 20mg DRUG

Belviq 20mg single dose administration

Belviq 20mg

Placebo DRUG

Placebo single dose administration

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is a healthy adult aged 18 \~ 60 years old at the time of screening.
• Subject has body weight index (BMI) 23.0 \~ 32.0.
• ☞ BMI(kg/m2) = weight (kg)/{height (m)}2
• Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
• Vital sign Supine SBP (mmHg) 90-140 DBP (mmHg) 50-90 Heart rate (beat/min) 40-80 Respiratory rate (breaths/min) 8-18
• Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam.
• SBP(mmHg) 90-140 DBP(mmHg) 50-90 Heart rate (beat/min) 40-80 Respiratory rate (breaths/min) 8-18
• Subject decided to participate voluntarily and gave written Informed consent to comply with the instructions after listening to and fully understanding the detailed explanation about this trial.

You may not qualify if:

• Subject has clinically significant liver, kidney, neurologic, immunologic, respiratory, endocrine disease or hematologic·oncologic disease, cardiovascular disease or psychiatric disease (mood disorder, compulsive disorder etc.) or such medical history (including subject with hepatitis virus in case of liver disease).
• Subject has history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or gastrointestinal surgery (except simple appendectomy or hernia operation) that can affect the absorption of the study drug.
• Subject has hypersensitivity reaction to drug (aspirin, antibiotics etc.) or history of clinically significant hypersensitivity reaction.
• Subject has history of drug abuse or tested positive to abused drug in the urine drug screening test (performed during screening and on Day -1).
• Subject took any prescribed drug or oriental medicine within 2 weeks prior to the first medication or any over-the-counter (OTC) drug or vitamins within 1 week prior to the first medication or paracetamol 48 hours prior to taking the study drug (however, the subject can be included if other criteria are met according to the discretion of the investigator).
• Subject participated in another study and received medication within 3 months prior to the first medication day (3 months are judged to be the period in between medications).
• Subject has history of using the following drug
• Fenfluramine/dexfenfluramine or phentermine
• Drug that may increase the risk of valvulopathy or primary pulmonary hypertension (Cyproheptadine, Trazodone, Nefazodone, Amoxapine, tricyclic antidepressants, mirtazapine, pergolide, ergotamine, methysergide).
• Subject received whole blood transfusion (500 mL) within 3 months prior to the first medication or blood transfusion within 1 month prior to the first medication.
• Subject continually drinks (in excess of 28 units/week (21 unit/week for women), 1 unit = 10 g of pure alcohol) or cannot abstain from drinking for 48 hours prior to the study drug administration through the hospitalization period.
• Subject smokes 3 cigarettes or more in one day or cannot abstain from smoking for 48 hours prior to the study drug administration through the hospitalization period.
• Subject took caffeine-containing food within 48 hours prior to the first medication, or cannot abstain from taking during the hospitalization period.
• Subject has tested positive to HbsAg, HCV Ab, HIV Ab tests.
• Subject has peculiar diet, is a vegetarian or consumes food that may affect the drug metabolism (e.g. St. John's Wort).

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Seoul National University Hospital

Jongno-gu, Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

lorcaserin

Study Officials

• Kyoung Sang You, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 19, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

KR (1)