CClinicalTrials.gg
Status unknownNCT02462031Updated Jun 3, 2015

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

A Phase 1 interventional study of KD101 and placebo in Obesity, sponsored by Kwang Dong Pharmaceutical co., ltd.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-03.

Sponsored by Kwang Dong Pharmaceutical co., ltd. · Phase 1 and Interventional

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Obesity

Browse trials for

03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's planned enrollment of 38 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Kwang Dong Pharmaceutical co., ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    KD101

    Drug: KD101

  • Placebo comparator
    KD101 placebo

    Drug: placebo

Interventions

  • DrugKD101

    200mg, 400mg, 800mg, 1400mg

    Also known as: KD101 soft capsule 200mg

  • Drugplacebo

    200mg, 400mg, 800mg

    Also known as: KD101 soft capsule 200mg placebo

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic parameters - Cmax

    Cmax (Maximum concentration of drug in plasma)

    Time frame: up to 4 weeks

Secondary outcomes

  1. Pharmacodynamic parameters - PBMCs

    PBMC (Peripheral blood mononuclear cell)

    Time frame: up to 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02462031
Lead sponsor
Kwang Dong Pharmaceutical co., ltd.
Responsible party
Sponsor
First posted
Jun 3, 2015
Start date
Mar 2015
Primary completion
Jan 2016 (estimated)
Completion
Mar 2016 (estimated)
Last update
Jun 3, 2015

Study contacts

Howard Lee, Professor
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion