To Evaluate the Safety, Tolerability, PK, PK-PD Relation of KD101 in the Fed State in Obese or Overweight Subjects

NCT ID: NCT02462031

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-03-31

Brief Summary

To Evaluate the safety, tolerability and pharmacokinetic property after KD101 multiple oral dosing in the fed state in obese or overweight subjects.

Detailed Description

dose block-randomized, double-blinded, placebo controlled, single or multiple ascending dose study. AEs, PE, Vital signs, ECGs and Clinical lab tests

• Part I : multiple dose study (KD101 or placebo) / male and female
• Part II : single dose study (KD101) / male only

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

KD101

Group Type: EXPERIMENTAL

KD101

Intervention Type: DRUG

200mg, 400mg, 800mg, 1400mg

KD101 placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

200mg, 400mg, 800mg

Interventions

KD101

200mg, 400mg, 800mg, 1400mg

Intervention Type: DRUG

placebo

200mg, 400mg, 800mg

Intervention Type: DRUG

Other Intervention Names

KD101 soft capsule 200mg; KD101 soft capsule 200mg placebo

Eligibility Criteria

Inclusion Criteria

• Male or Female adults aged 20 to 55 at screening (Part II : Male adults aged 20 to 55 at screening)
• Healthy volunteer whose BMI ≥ 27 (Part II : Healthy volunteer whose BMI ≥ 18)
• Female who are not pregnancy possibility or Male/Female who can abstinence or contraception during clinical trials

Exclusion Criteria

• Subjects who had clinically significant disease history (liver,kidney,nervous,pulmonary,endocrinal,urinary,cardiovascular,musculoskeletal,mental system,blood,tumor) or diagnosed within 1 month from screening
• Subjects who had gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) that affect the absorption of test drug or gastrointestinal operation (However, appendectomy, herniotomy induced by acute appendicitis are excluded)
• Subjects who had following history. [myocardial infarction (diagnosed by cardiac enzyme and/or diagnostic ECG), cerebral infarction/stroke, arrhythmia needed to medical treatment, unstable angina, pulmonary hypertension]
• Subjects who had positive result to Human Immunodeficiency Virus, Hepatitis B virus, Hepatitis C virus during screening
• Subjects who had allergy history (ex. allergy for aspirin, antibiotics, etc) or had clinically-significant allergy
• Subjects whose systolic BP was <85mmHg or >145mmHg, or diastolic BP was <50mmHg or >95mmHg, or pulse was >100/min after 3 minute-seating position. (BP can be re-measured twice at leat 5 minute-interval)
• Subjects who would take prescribed/oriental drug(within 2 weeks from the first dosing day) or OTC drug or vitamines (within 1 weeks from the first dosing day)
• Subjects who drink over than 21 unit (1 unit = 10g of pure alcohol) or cannot quit drinking alcohol during clinical trial period
• Subjects who ate following food within 2 days from the first dosing day or cannot quit following food [grapefruit-contain food, caffein-contain food(coffee, green tea, black tea, soft drink, coffee milk, energy drink)]
• Subjects who didn't agree contraception
• Subjects who didn't agree to quit smoke
• Subjects who donated his/her blood within 2 months (whole blood) / 1 month (apheresis) or who took transfusion within 1 month
• Subjects who participated another clinical trials within 3 months from first dosing day. (The clinical trial completion day is defined as the last dosing day of past clinical trial)
• Subjects who are not adequate to this trial by lab examination and another reasons
• Subjects who weighed loss more than 5kg in 3 months

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kwang Dong Pharmaceutical co., ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard Lee, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Howard Lee, Professor

Role: primary

leehwd@gmail.com

82 2 3668 7602

Other Identifiers

KD101-102

Identifier Type: -

Identifier Source: org_study_id