Phase I Clinical Study to Evauate the Tolerability and Pharmacokinetics of Belviq in Healthy Korean volunteers
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001063
- Lead Sponsor
- Ildong pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
1) Subject is a healthy adult aged ?18 and ?60 years old at the time of screening.
2) Subject has body weight index (BMI) ?23.0 and ?32.0.
? BMI(kg/m2) = weight (kg)/{height (m)}2
3) Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
4) 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
5) 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.
1) 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).
2) 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.
3) Subject has hypersensitivity reaction to drug (aspirin, antibiotics etc.) or history of clinically significant hypersensitivity reaction.
4) 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).
5) 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).
6) 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).
7) 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).
8) Subject donated whole blood transfusion (500 mL) within 3 months prior to the first medication or blood transfusion within 1 month prior to the first medication.
9) 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.
10) 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.
11) Subject took caffeine-containing food within 48 hours prior to the first medication, or cannot abstain from taking during the hospitalization period.
12) Subject has tested positive to HbsAg, HCV Ab, HIV Ab tests.
13) Subject has peculiar diet, is a vegetarian or consumes food that may affect the drug metabolism (e.g. St. John's Wort).
14) Subject had serious change in dietary habit or activity from 4 weeks prior to the study drug administration.
15) Subject or his/her partner cannot or is not willing to use appropriate contraceptives during the trial period and for 28 days after termination of the study (for women, exclusion criteria include pregnant or breastfeeding woman or woman who was confirmed to be pregnant in the pregnancy test).
16) Subject was judged not to be eligible according to the discretion of the investigator for other reasons.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Monitoring of adverse event realized by oneself or others;Vital signs;electrocardiography;clinical laboratory tests;physical exam;echocardiography
- Secondary Outcome Measures
Name Time Method CL/F, Vz/F of Belviq;Change in Belviq concentration in the blood with time;Cmax, Cmax/D, AUClast, AUClast/D, AUCinf, AUCinf/D, tmax, t1/2 of Belviq