HealthyPhase 1NCT01823133
Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin
A Phase 1 study testing gemigliptin only, rosuvastatin only and gemigliptin and rosuvastatin in people with Healthy, run by LG Life Sciences at 1 site in South Korea.
Trial summary
Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects 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?
- gemigliptin only, rosuvastatin only and gemigliptin and rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Aug 2013
- 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
- Age between 20 to 45, healthy male subjects (at screening)
- BMI between 18 - 27 kg/m2 (at screening)
- Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
- FPG 70-125mg/dL glucose level (at screening)
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the
Who cannot join
- Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- Subject who had GI tract disease that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- Subject who had drug hypersensitivity reaction.(gemigliptin, rosuvastatin, aspirin, antibiotics)
- Subject who already admitted in other investigator product in 80 days
- Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin in Healthy Male Subjects
Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects
- Conditions
- Healthy
- Being tested
- gemigliptin only, rosuvastatin only, gemigliptin and rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemigliptin onlyDrug
gemigliptin 50mg qd on day 1~7
rosuvastatin onlyDrug
rosuvastatin 20mg qd on day 1~7
gemigliptin and rosuvastatinDrug
gemigliptin 50mg, rosuvastatin 20mg qd on day 1~7
| Study group | Role | What they receive |
|---|---|---|
| gemigliptin only | Experimental | Multiple administrations of gemigliptin Receives: Drug: gemigliptin only |
| rosuvastatin only | Experimental | Multiple administrations of rosuvastatin Receives: Drug: rosuvastatin only |
| gemigliptin and rosuvastatin | Experimental | Multiple administrations of gemigliptin and rosuvastatin Receives: Drug: gemigliptin and rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
to evaluate Cmax of gemigliptin and rosuvastatin at steady state
Measured: up to 72 hour post dose
AUC
to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state
Measured: up to 72 hour post dose
Secondary outcomes (6)
Tmax
to evaluate time of Cmax at steady state, gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin
Measured: up to 72 hour post dose
Cmin
to evaluate Cmin of gemigliptin and rosuvastatin at steady state
Measured: upto 72 hour post dose
t1/2β
to evaluate half-life of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin
Measured: upto 72 hour post dose
Cmax
to evaluate Cmax of metabolite LC15-0636, N-desmethylrosuvastatin at steady state
Measured: upto 72 hour post dose
AUC
to evaluate AUC of metabolite LC15-0636, N-desmethylrosuvastatin at steady state
Measured: upto 72 hour post dose
metabolic ratio
to evaluate metabolic ratio of gemiglipin and rosuvastatin
Measured: upto 72 hour post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01823133
- Sponsor's protocol ID
- LG-GSCL001
- Status last verified
- Aug 2013
- First submitted
- 28 Mar 2013
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, Jung JH, Lee YK, Kim HJ, Bae KS. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015 Feb;31(2):229-41. doi: 10.1185/03007995.2014.980886. Epub 2014 Nov 6.
PubMed 25350224
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01823133
- Acronym / sponsor ID
- LG-GSCL001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Apr 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.
Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| gemigliptin only | Experimental | Drug: gemigliptin onlyMultiple administrations of gemigliptin |
| rosuvastatin only | Experimental | Drug: rosuvastatin onlyMultiple administrations of rosuvastatin |
| gemigliptin and rosuvastatin | Experimental | Drug: gemigliptin and rosuvastatinMultiple administrations of gemigliptin and rosuvastatin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20 to 45, healthy male subjects (at screening)
- BMI between 18 - 27 kg/m2 (at screening)
- Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
- FPG 70-125mg/dL glucose level (at screening)
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the
Key exclusion criteria (5 listed)
- Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- Subject who had GI tract disease that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- Subject who had drug hypersensitivity reaction.(gemigliptin, rosuvastatin, aspirin, antibiotics)
- Subject who already admitted in other investigator product in 80 days
- Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
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 |
|---|---|---|
| gemigliptin onlygemigliptin 50mg qd on day 1~7 | Drug | gemigliptin only |
| rosuvastatin onlyrosuvastatin 20mg qd on day 1~7 | Drug | rosuvastatin only |
| gemigliptin and rosuvastatingemigliptin 50mg, rosuvastatin 20mg qd on day 1~7 | Drug | gemigliptin and rosuvastatin |
Primary outcome
Cmax
Time frame: up to 72 hour post dose
to evaluate Cmax of gemigliptin and rosuvastatin at steady state
AUC
Time frame: up to 72 hour post dose
to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state
6 secondary outcomes
Tmax
Time frame: up to 72 hour post dose
Cmin
Time frame: upto 72 hour post dose
t1/2β
Time frame: upto 72 hour post dose
Cmax
Time frame: upto 72 hour post dose
AUC
Time frame: upto 72 hour post dose
metabolic ratio
Time frame: upto 72 hour post dose
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 28 Aug 2013.
- Derived from this study: PubMed 25350224Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, Jung JH, Lee YK, Kim HJ, Bae KS. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015 Feb;31(2):229-41. doi: 10.1185/03007995.2014.980886. Epub 2014 Nov 6.
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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 only, rosuvastatin only and gemigliptin and rosuvastatin in people with Healthy, run by LG Life Sciences 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 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 28 Aug 2013. 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?
Cmax (time frame: up to 72 hour post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01823133, which also lists 1 linked publication.
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 28 Aug 2013.