Clinical trial NCT02462031: To Evaluate the Safety, Tolerability, PK, PK-PD Relation of KD101 in the Fed State in Obese or Overweight Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Single or Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, PK, PK-PD Relation of KD101 in the Fed State in Obese or Overweight Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Kwang Dong Pharmaceutical co., ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

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

Primary outcomes:
measure: Pharmacokinetic parameters - Cmax
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Pharmacodynamic parameters - PBMCs
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Howard Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References: