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

NCT02462031 | Unknown Phase 1

• 1 other identifier: KD101-102
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters - Cmax

  Cmax (Maximum concentration of drug in plasma)

  up to 4 weeks

Secondary Outcomes (1)

• Pharmacodynamic parameters - PBMCs

  up to 4 weeks

Study Arms (2)

KD101

EXPERIMENTAL

Drug: KD101

KD101 placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

KD101 DRUG

200mg, 400mg, 800mg, 1400mg

Also known as: KD101 soft capsule 200mg

KD101

placebo DRUG

200mg, 400mg, 800mg

Also known as: KD101 soft capsule 200mg placebo

KD101 placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kwang Dong Pharmaceutical co., ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Howard Lee, Professor

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: June 3, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 3, 2015

Record last verified: 2015-05

Locations

KR (1)