Hepatic ImpairmentPhase 1NCT02004587
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
A Phase 1 study testing Gemigliptin in people with Hepatic Impairment, run by LG Life Sciences at 1 site in Germany.
Trial summary
The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Gemigliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Jul 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects who are able to understand and follow instructions during the study and available for study participation.
- Signed informed consent.
- White
Who cannot join
- Unwilling or unable to give informed consent.
- As a result of the medical screening process, a study physician considers the subject unfit for the study.
- The subject has a history of drug or other allergy which contraindicated study participation.
- Female subjects who are pregnant or lactating.
- Any other condition (surgical or medical) or history of severe disease with sequelae which increases the risk to the subject or affected absorption, distribution, metabolism or excretion of the study drug or otherwise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label Trial, Investigating the Pharmacokinetics, Pharmacodynamics and the Safety Profile After a Single Oral Dose of Gemigliptin (Investigational Product) in Healthy Subjects and Subjects With Mild or Moderate Hepatic Impairment and After Multiple Oral Dose in Healthy Subjects
The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.
- Conditions
- Hepatic Impairment
- Being tested
- Gemigliptin
- Keywords
- Hepatic impairment, Pharmacokinetics, Pharmacodynamics, Gemigliptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemigliptinDrug
Also called Zemiglo
Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment group | Experimental | Mild hepatic impairment group by Child-Pugh scores Receives: Drug: Gemigliptin |
| Moderate hepatic impairment group | Experimental | Moderate hepatic impairment group by Child-Pugh scores Receives: Drug: Gemigliptin |
| Healthy volunteers | Active comparator | Gemigliptin dosing in Healthy subjects Receives: Drug: Gemigliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Blood samples will be prepared at planed points.
Measured: Several time points until 72hr
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 startSep 2013
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004587
- Sponsor's protocol ID
- LG-DPCL014
- Status last verified
- Jul 2014
- First submitted
- 11 Nov 2013
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label Trial, Investigating the Pharmacokinetics, Pharmacodynamics and the Safety Profile After a Single Oral Dose of Gemigliptin (Investigational Product) in Healthy Subjects and Subjects With Mild or Moderate Hepatic Impairment and After Multiple Oral Dose in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02004587
- Acronym / sponsor ID
- LG-DPCL014
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic impairment, Pharmacokinetics, Pharmacodynamics, Gemigliptin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 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.
The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impairment group | Experimental | Drug: GemigliptinMild hepatic impairment group by Child-Pugh scores |
| Moderate hepatic impairment group | Experimental | Drug: GemigliptinModerate hepatic impairment group by Child-Pugh scores |
| Healthy volunteers | Active comparator | Drug: GemigliptinGemigliptin dosing in Healthy subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects who are able to understand and follow instructions during the study and available for study participation.
- Signed informed consent.
- White
Key exclusion criteria (5 listed)
- Unwilling or unable to give informed consent.
- As a result of the medical screening process, a study physician considers the subject unfit for the study.
- The subject has a history of drug or other allergy which contraindicated study participation.
- Female subjects who are pregnant or lactating.
- Any other condition (surgical or medical) or history of severe disease with sequelae which increases the risk to the subject or affected absorption, distribution, metabolism or excretion of the study drug or otherwise
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 |
|---|---|---|
| GemigliptinAlso: ZemigloGemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses. | Drug | Healthy volunteers, Mild hepatic impairment group, Moderate hepatic impairment group |
Primary outcome
AUC
Time frame: Several time points until 72hr
Blood samples will be prepared at planed points.
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 14 Jul 2014.
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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 Gemigliptin in people with Hepatic Impairment, run by LG Life Sciences at 1 site in Germany.
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 3 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 14 Jul 2014. 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 Germany. 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?
AUC (time frame: Several time points until 72hr). 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 14 Jul 2014.