HealthyPhase 1NCT00969787
DWP05195 in Healthy Adult Male Volunteers
A Phase 1 study testing DWP05195 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP05195 in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DWP05195
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2009to Nov 2009
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male subjects aged 20 to 45 years
- The subject has a Body weight ≥ 50 kg and < 90 kg and Body Mass Index (BMI) ≥ 19.0 kg/m2 and < 27.0 kg/m2
- A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
- A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
Who cannot join
- A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, gastrointestinal, hematology, neurology and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
- A subject who had any allergic history to any drug (prescription drug or OTC medication etc.)
- A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication
- Within last 1 month: drug or food known CYP1A2 inducer or inhibitor
- Within 2 weeks: Prescribed or herbal or Non-prescribed medicine
- Within 3 days: Consumption of grapefruit juice/grapefruit containing products or orange juice/orange containing products, garlic extracted functional foods
Show all 16Show fewer
- Within 3 days: Consumption of alcohol or caffeine
- A subject who had participated in any other clinical study within the last 12 weeks
- A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks
- A Subject with the known evidence of the following infections or drug abuse
- HIV, HBs, HCV
- cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine
- Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test
- AST or ALT greater than 1.5 times the upper limit of reference range or QTc > 430 msec base on screening results
- Blood pressure: SBP ≥ 140 mmHg, DBP ≤ 85 mmHg
- A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP05195 in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- DWP05195
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP05195Drug
tablets, oral administration, single and multiple administrations
| Study group | Role | What they receive |
|---|---|---|
| DWP05195 | Experimental | Not described Receives: Drug: DWP05195 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Safety & tolerability: Adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination
Measured: 72hr after drug administration
Secondary outcomes (1)
Pharmacokinetics: Cmax, tmax, AUC, and t½ in plasma / amount of drug, fraction, and CLr in urine Pharmacodynamics: Thermal NeuroSensory Analyser
Measured: 72 hr after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kyung-Sang Yu, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969787
- Sponsor's protocol ID
- DWP05195-P001
- Status last verified
- Aug 2009
- First submitted
- 13 Jul 2009
- Last updated
- 1 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DWP05195 in Healthy Adult Male Volunteers
- ClinicalTrials.gov ID
- NCT00969787
- Acronym / sponsor ID
- DWP05195-P001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- First posted
- 1 Sep 2009 (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.
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP05195 in healthy male volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DWP05195 | Experimental | Drug: DWP05195 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male subjects aged 20 to 45 years
- The subject has a Body weight ≥ 50 kg and < 90 kg and Body Mass Index (BMI) ≥ 19.0 kg/m2 and < 27.0 kg/m2
- A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
- A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
Key exclusion criteria (16 listed)
- A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, gastrointestinal, hematology, neurology and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
- A subject who had any allergic history to any drug (prescription drug or OTC medication etc.)
- A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication
- A subject who had participated in any other clinical study within the last 12 weeks
- A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks
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 |
|---|---|---|
| DWP05195tablets, oral administration, single and multiple administrations | Drug | DWP05195 |
Primary outcome
Assessment of Safety & tolerability: Adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination
Time frame: 72hr after drug administration
1 secondary outcome
Pharmacokinetics: Cmax, tmax, AUC, and t½ in plasma / amount of drug, fraction, and CLr in urine Pharmacodynamics: Thermal NeuroSensory Analyser
Time frame: 72 hr after drug administration
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 1 Apr 2010.
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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.
Kyung-Sang Yu 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 DWP05195 in people with Healthy, run by Daewoong 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 16 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 1 Apr 2010. 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?
Assessment of Safety & tolerability: Adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination (time frame: 72hr after drug administration). 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 1 Apr 2010; AzTrials last refreshed its copy on 8 Nov 2026.