Liver DysfunctionPhase 1NCT02754219
Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction
A Phase 1 study testing Evogliptin in people with Liver Dysfunction, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Dysfunction
- What is being tested?
- Evogliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Sep 2016to 19 Jan 2018
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- <Hepatic Dysfunction>
- At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction)
- Child-Pugh A or B
- <Healthy Control>
- Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject
Who cannot join
- <Hepatic Dysfunction>
- Child-Pugh C
- History of Liver transplant
- <Healthy Control>
- History of chronic liver disorders
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction and Control Healthy Volunteers
The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin
Read the detailed description
When the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.
- Conditions
- Liver Dysfunction
- Being tested
- Evogliptin
- Keywords
- Diabetes Mellitus, Type II
- Medical subject headings
- Liver Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvogliptinDrug
Also called DA-1229
DPP4-inhibitor, Evogliptin
| Study group | Role | What they receive |
|---|---|---|
| Evogliptin | Experimental | Hepatic dysfunction, Healthy control Receives: Drug: Evogliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic(Cmax of Evogliptin)
Measured: Day1, Day2, Day3, Day4, Day5, Day6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start22 Sep 2016
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DysfunctionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754219
- Sponsor's protocol ID
- DA1229_HI_I
- Status last verified
- Feb 2018
- First submitted
- 27 Apr 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction and Control Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02754219
- Acronym / sponsor ID
- DA1229_HI_I
- Conditions
- Liver Dysfunction
- Keywords
- Diabetes Mellitus, Type II
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 28 Apr 2016 (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 objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin
Detailed description
When the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evogliptin | Experimental | Drug: EvogliptinHepatic dysfunction, Healthy control |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- <Hepatic Dysfunction>
- At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction)
- Child-Pugh A or B
- <Healthy Control>
- Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject
Key exclusion criteria (6 listed)
- <Hepatic Dysfunction>
- Child-Pugh C
- History of Liver transplant
- <Healthy Control>
- History of chronic liver disorders
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 |
|---|---|---|
| EvogliptinAlso: DA-1229DPP4-inhibitor, Evogliptin | Drug | Evogliptin |
Primary outcome
Pharmacokinetic(Cmax of Evogliptin)
Time frame: Day1, Day2, Day3, Day4, Day5, Day6
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 26 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Evogliptin in people with Liver Dysfunction, run by Dong-A ST 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 5 inclusion and 6 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 26 Feb 2018. 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?
Pharmacokinetic(Cmax of Evogliptin) (time frame: Day1, Day2, Day3, Day4, Day5, Day6). 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 26 Feb 2018.