Drug ToxicityPhase 1NCT01979380
Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects
A Phase 1 study testing KD101 in people with Drug Toxicity, run by Kwang Dong Pharmaceutical co., ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Toxicity
- What is being tested?
- KD101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Single Oral Dose, Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects
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
Read the detailed description
This clinical trial is a dose block-randomized, double-blinded, placebo controlled, single ascending dose, food interaction study. AEs, PE, Vital signs, ECGs and clinical lab tests will be assessed to evaluate the safety and tolerability, and blood and urine will be collected to evaluate the pharmacokinetic parameters.
This single ascending dose, food interaction study will be conducted with the KD101 dose of 200, 600, 1000 and 1400 mg. After evaluating the safety and pharmacokinetic parameters in the single dose KD101 group of 200mg, next higher dose of KD101 will be administered and evaluated and food interaction will be evaluated in the KD101 group of 600mg.
- Conditions
- Drug Toxicity
- Being tested
- KD101, placebo
- Keywords
- KD101, Anti-obesity Agents
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD101Drug
Also called KD101 soft capsule 200mg
200mg (1casule), 600mg (3 capsule), 1000mg (5 capsule), 1400mg (7 capsule) PO, once in the morning
placeboDrug
Also called KD101 placebo
PO, once in the morning
| Study group | Role | What they receive |
|---|---|---|
| KD101 | Experimental | Not described Receives: Drug: KD101 |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, AUClast, AUCinf, Tmax, t1/2, fe, CL/F, Vd/F, % AUCextra, CLR
Measured: single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwang Dong Pharmaceutical co., ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Lee, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979380
- Sponsor's protocol ID
- KD101-101
- Status last verified
- Aug 2014
- First submitted
- 4 Nov 2013
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Ascending Single Oral Dose, Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01979380
- Acronym / sponsor ID
- KD101-101
- Conditions
- Drug Toxicity
- Keywords
- KD101, Anti-obesity Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kwang Dong Pharmaceutical co., ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This clinical trial is a dose block-randomized, double-blinded, placebo controlled, single ascending dose, food interaction study. AEs, PE, Vital signs, ECGs and clinical lab tests will be assessed to evaluate the safety and tolerability, and blood and urine will be collected to evaluate the pharmacokinetic parameters.
This single ascending dose, food interaction study will be conducted with the KD101 dose of 200, 600, 1000 and 1400 mg. After evaluating the safety and pharmacokinetic parameters in the single dose KD101 group of 200mg, next higher dose of KD101 will be administered and evaluated and food interaction will be evaluated in the KD101 group of 600mg.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KD101 | Experimental | Drug: KD101 |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KD101Also: KD101 soft capsule 200mg200mg (1casule), 600mg (3 capsule), 1000mg (5 capsule), 1400mg (7 capsule) PO, once in the morning | Drug | KD101 |
| placeboAlso: KD101 placeboPO, once in the morning | Drug | placebo |
Primary outcome
Cmax, AUClast, AUCinf, Tmax, t1/2, fe, CL/F, Vd/F, % AUCextra, CLR
Time frame: single dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
Related trials for Drug Toxicity
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Not yet recruiting
Feasibility Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Advanced Colorectal Cancer
Advanced Colorectal Cancer, Capecitabine-Related Adverse Reaction
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Active, not recruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Melanoma Stage III, Melanoma Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Lee, Professor principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KD101 in people with Drug Toxicity, run by Kwang Dong Pharmaceutical co., ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax, AUClast, AUCinf, Tmax, t1/2, fe, CL/F, Vd/F, % AUCextra, CLR (time frame: single dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.