Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects

NCT01979380 | Completed Phase 1

• 1 other identifier: KD101-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male subjects To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male subjects To Evaluate the effect of food on bioavailability after KD101 single oral dosing in healthy male subjects

Conditions

Drug Toxicity

Keywords

KD101; Anti-obesity Agents

Outcome Measures

Primary Outcomes (1)

• Cmax, AUClast, AUCinf, Tmax, t1/2, fe, CL/F, Vd/F, % AUCextra, CLR

  single dose

Study Arms (2)

KD101

EXPERIMENTAL

Drug: KD101

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

KD101 DRUG

200mg (1casule), 600mg (3 capsule), 1000mg (5 capsule), 1400mg (7 capsule) PO, once in the morning

Also known as: KD101 soft capsule 200mg

KD101

placebo DRUG

PO, once in the morning

Also known as: KD101 placebo

placebo

Eligibility Criteria

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

You may qualify if:

• Subjects who listened the properties of this clinical trial and signed IRB approved-ICF by voluntary consent
• Male adults aged 20 to 55 years at screening
• Healthy volunteer whose BMI ≥ 18
• Subjects who are adequate to this trial by physical examination, lab examination, diagnosis from physician

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 / or were suspected to 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 reason

Sponsors & Collaborators

• Kwang Dong Pharmaceutical co., ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

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: November 4, 2013
• First Posted: November 8, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 12, 2014

Record last verified: 2014-08

Locations

KR (1)