Diabete MellitusPhase 1NCT03769870
Teneligliptin and Atorvastatin DDI Study
A Phase 1 study testing Teneligliptin 20mg/day, Atorvastatin 40mg/Day and Teneligliptin 20mg/day + Atorvastatin 40mg/day in people with Diabete Mellitus, run by Handok Inc. at 1 site in South Korea.
Trial summary
A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults 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
- Diabete Mellitus
- What is being tested?
- Teneligliptin 20mg/day, Atorvastatin 40mg/Day and Teneligliptin 20mg/day + Atorvastatin 40mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jan 2019to 25 Feb 2019
- 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
- Healthy male adult 19 to 45 years
- Body weight ≥ 50kg, and BMI between 18-29kg/m2 at screening
- Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
- Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Cross-over, Multiple Dosing Study to Evaluate Drug-drug Interaction Between Teneligliptin and Atorvastatin in Healthy Male Adults
A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults
- Conditions
- Diabete Mellitus
- Being tested
- Teneligliptin 20mg/day, Atorvastatin 40mg/Day, Teneligliptin 20mg/day + Atorvastatin 40mg/day
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teneligliptin 20mg/dayDrug
cross-over
Atorvastatin 40mg/DayDrug
cross-over
Teneligliptin 20mg/day + Atorvastatin 40mg/dayDrug
cross-over
| Study group | Role | What they receive |
|---|---|---|
| Teneligliptin | Other | Not described Receives: Drug: Teneligliptin 20mg/day |
| Atorvastatin | Other | Not described Receives: Drug: Atorvastatin 40mg/Day |
| Teneligliptin + Atorvastatin | Other | Not described Receives: Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss(Maximum concentration at steady state)
Measured: 24 hours
AUCτ,ss(Area under the concentration-time curve at steady state)
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start11 Jan 2019
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769870
- Sponsor's protocol ID
- MP_C104
- Status last verified
- May 2019
- First submitted
- 6 Dec 2018
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Cross-over, Multiple Dosing Study to Evaluate Drug-drug Interaction Between Teneligliptin and Atorvastatin in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT03769870
- Acronym / sponsor ID
- MP_C104
- Conditions
- Diabete Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 10 Dec 2018 (actual)
- 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.
A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Teneligliptin | Other | Drug: Teneligliptin 20mg/day |
| Atorvastatin | Other | Drug: Atorvastatin 40mg/Day |
| Teneligliptin + Atorvastatin | Other | Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male adult 19 to 45 years
- Body weight ≥ 50kg, and BMI between 18-29kg/m2 at screening
- Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
- Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Teneligliptin 20mg/daycross-over | Drug | Teneligliptin |
| Atorvastatin 40mg/Daycross-over | Drug | Atorvastatin |
| Teneligliptin 20mg/day + Atorvastatin 40mg/daycross-over | Drug | Teneligliptin + Atorvastatin |
Primary outcome
Cmax,ss(Maximum concentration at steady state)
Time frame: 24 hours
AUCτ,ss(Area under the concentration-time curve at steady state)
Time frame: 24hours
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 30 May 2019.
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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 Teneligliptin 20mg/day, Atorvastatin 40mg/Day and Teneligliptin 20mg/day + Atorvastatin 40mg/day in people with Diabete Mellitus, run by Handok Inc. 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 4 inclusion and 0 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 30 May 2019. 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,ss(Maximum concentration at steady state) (time frame: 24 hours). 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?
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 30 May 2019.