HealthyPhase 1NCT02622685
A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects
A Phase 1 study testing DWP10292 and Ursodeoxycholic acid (UDCA) in people with Healthy, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DWP10292 and Ursodeoxycholic acid (UDCA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Feb 2016
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
- Healthy adult male subjects aged 19 to 45 years
- The subject has a Body weight ≥ 60 kg and < 90 kg and Body Mass Index(BMI) ≥ 18.5 kg/m2 and < 27.0 kg/m2
- 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 liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
- A subject who shows vital signs with the number of systolic blood pressure of ≥140 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥90mmHg or ≤60mmHg
- A subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month) or received a blood transfusion within last 1 month
- Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial)
- Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the clinical trial
About this study
Official title: A Dose Block-randomized, Double-blind, Placebo Controlled, Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of DWP10292 and Ursodeoxycholic Acid in Healthy Male Subjects
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.
Read the detailed description
This study is dose block-randomized, double-blind, placebo controlled, multiple-dosing, dose escalation clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of DWP 10292 after oral administration in healthy male subjects.
- Conditions
- Healthy
- Being tested
- DWP10292, DWP10292 Placebo, Ursodeoxycholic acid (UDCA), UDCA Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP10292Drug
Drug: DWP10292 tablets, oral administration, multiple administration
DWP10292 PlaceboDrug
Placebo tablets, oral administration, multiple administrations
Ursodeoxycholic acid (UDCA)Drug
Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration
UDCA PlaceboDrug
Placebo tablets, oral administration, multiple administrations
| Study group | Role | What they receive |
|---|---|---|
| DWP10292 | Experimental | Drug: DWP10292 DWP10292 tablets, oral administration, multiple administration
Arms: DWP10292 Receives: Drug: DWP10292 |
| DWP10292 Placebo | Placebo comparator | Drug: Placebo Placebo tablets, oral administration, multiple administrations
Arms: Placebo Receives: Drug: DWP10292 Placebo |
| Ursodeoxycholic acid (UDCA) | Experimental | Drug: Ursodeoxycholic acid (UDCA) UDCA tablets, oral administration, multiple administrations
Arms: Ursodeoxycholic acid (UDCA) Receives: Drug: Ursodeoxycholic acid (UDCA) |
| Ursodeoxycholic acid (UDCA) Placebo | Placebo comparator | Drug: Placebo Placebo tablets, oral administration, multiple administrations
Arms: Placebo Receives: Drug: UDCA Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Pharmacokinetics
Peak Plasma Concentration (Cmax)
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Composite of Pharmacokinetics
Area under the plasma concentration versus time curve (AUC)
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Composite of Pharmacokinetics
Mean residence time (MRT)
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Composite of Pharmacokinetics
Accumulation index
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Secondary outcomes (1)
[Safety & tolerability] Incidence of adverse events related with drug
Adverse events, Physical exam, Vital sign, laboratory (CBC, chemistry, U/A etc)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622685
- Sponsor's protocol ID
- DW_P10292002P
- Status last verified
- Jun 2016
- First submitted
- 30 Apr 2015
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Block-randomized, Double-blind, Placebo Controlled, Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of DWP10292 and Ursodeoxycholic Acid in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02622685
- Acronym / sponsor ID
- DW_P10292002P
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Dec 2015 (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 DWP10292 and UDCA in healthy male volunteers after multiple-dosing.
Detailed description
This study is dose block-randomized, double-blind, placebo controlled, multiple-dosing, dose escalation clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of DWP 10292 after oral administration in healthy male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DWP10292 | Experimental | Drug: DWP10292Drug: DWP10292 DWP10292 tablets, oral administration, multiple administration Arms: DWP10292 |
| DWP10292 Placebo | Placebo comparator | Drug: DWP10292 PlaceboDrug: Placebo Placebo tablets, oral administration, multiple administrations Arms: Placebo |
| Ursodeoxycholic acid (UDCA) | Experimental | Drug: Ursodeoxycholic acid (UDCA)Drug: Ursodeoxycholic acid (UDCA) UDCA tablets, oral administration, multiple administrations Arms: Ursodeoxycholic acid (UDCA) |
| Ursodeoxycholic acid (UDCA) Placebo | Placebo comparator | Drug: UDCA PlaceboDrug: Placebo Placebo tablets, oral administration, multiple administrations Arms: Placebo |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
- Healthy adult male subjects aged 19 to 45 years
- The subject has a Body weight ≥ 60 kg and < 90 kg and Body Mass Index(BMI) ≥ 18.5 kg/m2 and < 27.0 kg/m2
- 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 (5 listed)
- A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
- A subject who shows vital signs with the number of systolic blood pressure of ≥140 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥90mmHg or ≤60mmHg
- A subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month) or received a blood transfusion within last 1 month
- Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial)
- Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the clinical trial
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 |
|---|---|---|
| DWP10292Drug: DWP10292 tablets, oral administration, multiple administration | Drug | DWP10292 |
| DWP10292 PlaceboPlacebo tablets, oral administration, multiple administrations | Drug | DWP10292 Placebo |
| Ursodeoxycholic acid (UDCA)Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration | Drug | Ursodeoxycholic acid (UDCA) |
| UDCA PlaceboPlacebo tablets, oral administration, multiple administrations | Drug | Ursodeoxycholic acid (UDCA) Placebo |
Primary outcome
Composite of Pharmacokinetics
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Peak Plasma Concentration (Cmax)
Composite of Pharmacokinetics
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Area under the plasma concentration versus time curve (AUC)
Composite of Pharmacokinetics
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Mean residence time (MRT)
Composite of Pharmacokinetics
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Accumulation index
1 secondary outcome
[Safety & tolerability] Incidence of adverse events related with drug
Time frame: 4 weeks
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 2 Jun 2016.
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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 DWP10292 and Ursodeoxycholic acid (UDCA) in people with Healthy, 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 5 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 2 Jun 2016. 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. 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?
Composite of Pharmacokinetics (time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods). The study lists 4 primary outcomes in all. 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 2 Jun 2016.