Diabetic Kidney DiseasePhase 1NCT02004327
The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer
A Phase 1 study testing DW1029M300mg, DW1029M600mg and DW1029M1200mg in people with Diabetic Kidney Disease, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
1. Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics. 2. Indication Diabetic kidney disease 3. Efficacy 1. Primary AUClast, AUCinf, AUClast/D, AUCinf/D Cmax, Cmax/D 2. Secondary Tmax, t1/2, CL/F, Vz/F 4. Safety 1. 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
- Diabetic Kidney Disease
- What is being tested?
- DW1029M300mg, DW1029M600mg and DW1029M1200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Jun 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
- More than 20 years of age at the time of screening and less than 55 years old healthy male
- (17.5 ~ 30.5 kg/m2 body mass index (BMI) and weight 45 kg or more
- ☞ body mass index (BMI) = weight (kg) / height (m) 2
- No congenital or chronic diseases, internal medicine examination results who does not have psychotic symptoms or findings
Who cannot join
- Clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but, at the time of administration of seasonal allergic untreated asymptomatic except for sex), medical history or evidence
- Drugs that may affect the absorption of all the states (eg, gastrectomy)
- Investigational drugs within two months before the first dose participated in other clinical trials
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital
Jeonju-si, Jeollabuk-do, Geonjiro, Deokjin-gu, 561-712
About this study
Official title: Randomized, Open-label, Single Dose, Crossover Phase I Clinical Study to Evaluate the Pharmacokinetics of DW1029M 300 mg, 600 mg and 1200 mg After Oral Administration in Healthy Male Volunteer
- Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics.
- Indication Diabetic kidney disease
- Efficacy
- Primary
- AUClast, AUCinf, AUClast/D, AUCinf/D
- Cmax, Cmax/D
- Secondary
- Tmax, t1/2, CL/F, Vz/F
- Safety
- Adverse Event Monitoring
- V/S, EKG, Laboratory Test, P/E
Read the detailed description
Healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks from the (-21d ~-1d) in the interview, physical examination and laboratory tests , including through the screening is performed.
Through screening deems appropriate in this clinical trial is intended for the final subjects randomized to three groups to order .
The first phase one clinical trial subjects performed one day before (the -1 ) 18:00 Chonbuk National University Hospital, convened as a physical examination and perform hwalryeong signs .
One person to dinner , except for the drinking water should be fasting . One clinical trials (the first day) 20:00 subjects randomly assigned to groups according to the order in which the test is administered in a single oral medication .
The subjects for clinical trials with 240 mL water, medicines and swallow whole , chew before swallowing drugs should .
Blood according to the schedule after the clinical trial , including vital signs and physical examination is performed. The subjects that had a fixed schedule and is discharged on the morning of the second .
Is at least one week washout period . Since the two groups according to the order group and three creeping dose , except for the one the same tiles to proceed.
After a period of three clinical trials, three day period from taking drugs for clinical trials after 3-5 days to perform the post-study visit .
- Conditions
- Diabetic Kidney Disease
- Being tested
- DW1029M300mg, DW1029M600mg, DW1029M1200mg
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW1029M300mgDrug
Also called DW1029M300mg 1 tablet
DW1029M300mg PO Once
DW1029M600mgDrug
Also called DW1029M300mg 2 tablets
DW1029M300mg 2 tablets Once
DW1029M1200mgDrug
Also called DW1029M300mg 4 tablets
DW1029M300mg 4 tablets PO Once
| Study group | Role | What they receive |
|---|---|---|
| A Group | Experimental | 1. 1st administration - DW1029M300mg PO Once
2. 2nd administration - DW1029M600mg PO Once
3. 3rd administration - DW1029M1200mg PO Once Receives: Drug: DW1029M300mg; Drug: DW1029M600mg; Drug: DW1029M1200mg |
| B Group | Experimental | 1. 1st administration - DW1029M600mg PO Once
2. 2nd administration - DW1029M1200mg PO Once
3. 3rd administration - DW1029M300mg PO Once Receives: Drug: DW1029M300mg; Drug: DW1029M600mg; Drug: DW1029M1200mg |
| C Group | Experimental | 1. 1st administration - DW1029M1200mg PO Once
2. 2nd administration - DW1029M300mg PO Once
3. 3rd administration - DW1029M600mg PO Once Receives: Drug: DW1029M300mg; Drug: DW1029M600mg; Drug: DW1029M1200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration of DW1029M in plasma
Measured: 24 hours
Secondary outcomes (5)
Area under concentration-time curve of DW1029M in plasma
Measured: 24hours
Time to maximal concentration of DW1029M in Plasma
Measured: 24hours
Elimination half time of DW1029M in Plasma
Measured: 24hours
Apparent clearance of DW1029M in Plasma
Measured: 24hours
Apparent volume of distribution of DW1029M in Plasma
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheol-hee Lim, CR Manager, Study director, DongWha Pharmaceutical Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004327
- Sponsor's protocol ID
- DW1029M-I-3
- Status last verified
- Jun 2015
- First submitted
- 14 Nov 2013
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Single Dose, Crossover Phase I Clinical Study to Evaluate the Pharmacokinetics of DW1029M 300 mg, 600 mg and 1200 mg After Oral Administration in Healthy Male Volunteer
- ClinicalTrials.gov ID
- NCT02004327
- Acronym / sponsor ID
- DW1029M-I-3
- Conditions
- Diabetic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Dec 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.
- Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics.
- Indication Diabetic kidney disease
- Efficacy
- Primary
- AUClast, AUCinf, AUClast/D, AUCinf/D
- Cmax, Cmax/D
- Secondary
- Tmax, t1/2, CL/F, Vz/F
- Safety
- Adverse Event Monitoring
- V/S, EKG, Laboratory Test, P/E
Detailed description
Healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks from the (-21d ~-1d) in the interview, physical examination and laboratory tests , including through the screening is performed.
Through screening deems appropriate in this clinical trial is intended for the final subjects randomized to three groups to order .
The first phase one clinical trial subjects performed one day before (the -1 ) 18:00 Chonbuk National University Hospital, convened as a physical examination and perform hwalryeong signs .
One person to dinner , except for the drinking water should be fasting . One clinical trials (the first day) 20:00 subjects randomly assigned to groups according to the order in which the test is administered in a single oral medication .
The subjects for clinical trials with 240 mL water, medicines and swallow whole , chew before swallowing drugs should .
Blood according to the schedule after the clinical trial , including vital signs and physical examination is performed. The subjects that had a fixed schedule and is discharged on the morning of the second .
Is at least one week washout period . Since the two groups according to the order group and three creeping dose , except for the one the same tiles to proceed.
After a period of three clinical trials, three day period from taking drugs for clinical trials after 3-5 days to perform the post-study visit .
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A Group | Experimental | Drug: DW1029M300mg, Drug: DW1029M600mg, Drug: DW1029M1200mg1. 1st administration - DW1029M300mg PO Once 2. 2nd administration - DW1029M600mg PO Once 3. 3rd administration - DW1029M1200mg PO Once |
| B Group | Experimental | Drug: DW1029M300mg, Drug: DW1029M600mg, Drug: DW1029M1200mg1. 1st administration - DW1029M600mg PO Once 2. 2nd administration - DW1029M1200mg PO Once 3. 3rd administration - DW1029M300mg PO Once |
| C Group | Experimental | Drug: DW1029M300mg, Drug: DW1029M600mg, Drug: DW1029M1200mg1. 1st administration - DW1029M1200mg PO Once 2. 2nd administration - DW1029M300mg PO Once 3. 3rd administration - DW1029M600mg PO Once |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- More than 20 years of age at the time of screening and less than 55 years old healthy male
- (17.5 ~ 30.5 kg/m2 body mass index (BMI) and weight 45 kg or more
- ☞ body mass index (BMI) = weight (kg) / height (m) 2
- No congenital or chronic diseases, internal medicine examination results who does not have psychotic symptoms or findings
Key exclusion criteria (3 listed)
- Clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but, at the time of administration of seasonal allergic untreated asymptomatic except for sex), medical history or evidence
- Drugs that may affect the absorption of all the states (eg, gastrectomy)
- Investigational drugs within two months before the first dose participated in other clinical trials
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 |
|---|---|---|
| DW1029M300mgAlso: DW1029M300mg 1 tabletDW1029M300mg PO Once | Drug | A Group, B Group, C Group |
| DW1029M600mgAlso: DW1029M300mg 2 tabletsDW1029M300mg 2 tablets Once | Drug | A Group, B Group, C Group |
| DW1029M1200mgAlso: DW1029M300mg 4 tabletsDW1029M300mg 4 tablets PO Once | Drug | A Group, B Group, C Group |
Primary outcome
Maximum Concentration of DW1029M in plasma
Time frame: 24 hours
5 secondary outcomes
Area under concentration-time curve of DW1029M in plasma
Time frame: 24hours
Time to maximal concentration of DW1029M in Plasma
Time frame: 24hours
Elimination half time of DW1029M in Plasma
Time frame: 24hours
Apparent clearance of DW1029M in Plasma
Time frame: 24hours
Apparent volume of distribution of DW1029M in Plasma
Time frame: 24hours
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 29 Jun 2015.
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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.
Cheol-hee Lim, CR Manager study director
DongWha Pharmaceutical Company
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 DW1029M300mg, DW1029M600mg and DW1029M1200mg in people with Diabetic Kidney Disease, run by Dong Wha 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 3 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 29 Jun 2015. 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. 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?
Maximum Concentration of DW1029M in plasma (time frame: 24 hours). 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 29 Jun 2015.