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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02462031
• Other study ID #: KD101-102
• Status: Recruiting
• Phase: Phase 1
• First received: May 6, 2015
• Last updated: June 2, 2015
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2015
• Source: Kwang Dong Pharmaceutical co., ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• KD101
200mg, 400mg, 800mg, 1400mg
• placebo
200mg, 400mg, 800mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kwang Dong Pharmaceutical co., ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters - Cmax	Cmax (Maximum concentration of drug in plasma)	up to 4 weeks	Yes
Secondary	Pharmacodynamic parameters - PBMCs	PBMC (Peripheral blood mononuclear cell)	up to 4 weeks	No