Healthy Adult VolunteersPhase 1NCT01094834
A Multiple Dose Study of DWP05195 in Healthy Adult Subjects
A Phase 1 study testing DWP05195 in people with Healthy Adult Volunteers, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple administered DWP05195 in healthy 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 Adult Volunteers
- 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
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Oct 2010
- 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
- 1. 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 2. A subject who had any allergic history to any drug (prescription drug or OTC medication etc.) 3. 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
- Within 3 days : Consumption of alcohol or caffeine 4. A subject who had participated in any other clinical study within the last 12 weeks 5. A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks 6. A Subject with the known evidence of the following infections or drug abuse
- HIV, HBs, HCV
- cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine 7. Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test 8. AST or ALT greater than 1.5 times the upper limit of reference range or QTc > 430 msec base on screening results 9. Blood pressure : SBP≥140mmHg, DBP≤85mmHg 10. A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests
About this study
Official title: A Multiple Dose Study To Determine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP05195 in Healthy Adult Subjects
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple administered DWP05195 in healthy volunteers
- Conditions
- Healthy Adult Volunteers
- 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, multiple administration
| 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: 17 days 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 posted29 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094834
- Sponsor's protocol ID
- DWP05195-P002
- Status last verified
- Feb 2011
- First submitted
- 26 Mar 2010
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study To Determine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP05195 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01094834
- Acronym / sponsor ID
- DWP05195-P002
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- First posted
- 29 Mar 2010 (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 multiple administered DWP05195 in healthy 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 (7 listed)
- 1. 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 2. A subject who had any allergic history to any drug (prescription drug or OTC medication etc.) 3. 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
- Within 3 days : Consumption of alcohol or caffeine 4. A subject who had participated in any other clinical study within the last 12 weeks 5. A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks 6. A Subject with the known evidence of the following infections or drug abuse
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, multiple administration | Drug | DWP05195 |
Primary outcome
Assessment of safety & tolerability: adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination
Time frame: 17 days 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 9 Feb 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWP05195 in people with Healthy Adult Volunteers, run by Daewoong Pharmaceutical Co. LTD..
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 7 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 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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: 17 days 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 9 Feb 2011.