Diabetes MellitusPhase 1NCT00960453
Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin
A Phase 1 study testing Sitagliptin in people with Diabetes Mellitus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of sitagliptin in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Sep 2009
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 20 - 50 years
- A body mass index (BMI) in the range 17-28 kg/m2
- Fasting plasma glucose levels in the range 70-110 mg/dL
- Sufficient ability to understand the nature of the study and any hazards of participating in it
- Provide written informed consent after being fully informed about the study procedures
Who cannot join
- Presence or history of severe adverse reaction to any drug (e.g., sitagliptin) or a history of severe allergic disease
- Clinically relevant abnormal medical history that could interfere with the objectives of the study
- A subject who has the following screening laboratory test results; creatinine clearance (calculated by Cockcroft-Gault equation) < 80 mL/min
- History of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- A subject whose SBP is over 150 mmHg or below 100 mmHg and DBP is over 95 mmHg or below 65 mmHg
- Presence or history of drug abuse
Show all 13Show fewer
- Participation in other clinical trial within 2 months
- Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose
- Blood donation during 2 months or apheresis during 1 month before the study
- Presence or history of alcohol abuse
- Users of nicotine-containing substances within the previous three months
- Use of grapefruit juice, alcohol or smoking during restriction period
- Subject judged not eligible for study participation by investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trials Center; Seoul National University Hospital
Seoul, 110-744
About this study
Official title: Multiple-dose, Dose Escalation Study to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin in Healthy Male Volunteers
The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of sitagliptin in healthy volunteers.
- Conditions
- Diabetes Mellitus
- Being tested
- Sitagliptin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Dosage form: 25mg, 50mg ,100mg
Amount: 25mg, 50mg, 100mg
Frequency and duration: once a day, for 4 days, including 5 days washout periods
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin 25mg | Other | Repeated administrations for 4 days Receives: Drug: Sitagliptin |
| Sitagliptin 50mg | Other | Repeated administrations for 4 days Receives: Drug: Sitagliptin |
| Sitagliptin 100mg | Other | Repeated administrations for 4 days Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetics after repeated administrations of sitagliptin 25, 50 and 100 mg
Measured: Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration
To evaluate the pharmacodynamics (activity of Dipeptidyl peptidase-IV enzyme) after repeated administrations of sitagliptin 25, 50 and 100 mg
Measured: Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startDec 2008
- Primary completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kyung-Sang Yu, MD, PhD, Principal investigator, Seoul National University College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960453
- Sponsor's protocol ID
- SNUCPT09_Sitagliptin
- Status last verified
- Feb 2011
- First submitted
- 14 Aug 2009
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-dose, Dose Escalation Study to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00960453
- Acronym / sponsor ID
- SNUCPT09_Sitagliptin
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2009 (actual)
- First posted
- 17 Aug 2009 (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 investigate the pharmacokinetics and pharmacodynamics of sitagliptin in healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin 25mg | Other | Drug: SitagliptinRepeated administrations for 4 days |
| Sitagliptin 50mg | Other | Drug: SitagliptinRepeated administrations for 4 days |
| Sitagliptin 100mg | Other | Drug: SitagliptinRepeated administrations for 4 days |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects aged 20 - 50 years
- A body mass index (BMI) in the range 17-28 kg/m2
- Fasting plasma glucose levels in the range 70-110 mg/dL
- Sufficient ability to understand the nature of the study and any hazards of participating in it
- Provide written informed consent after being fully informed about the study procedures
Key exclusion criteria (13 listed)
- Presence or history of severe adverse reaction to any drug (e.g., sitagliptin) or a history of severe allergic disease
- Clinically relevant abnormal medical history that could interfere with the objectives of the study
- A subject who has the following screening laboratory test results; creatinine clearance (calculated by Cockcroft-Gault equation) < 80 mL/min
- History of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- A subject whose SBP is over 150 mmHg or below 100 mmHg and DBP is over 95 mmHg or below 65 mmHg
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 |
|---|---|---|
| SitagliptinDosage form: 25mg, 50mg ,100mg Amount: 25mg, 50mg, 100mg Frequency and duration: once a day, for 4 days, including 5 days washout periods | Drug | Sitagliptin 100mg, Sitagliptin 25mg, Sitagliptin 50mg |
Primary outcome
To evaluate the pharmacokinetics after repeated administrations of sitagliptin 25, 50 and 100 mg
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration
To evaluate the pharmacodynamics (activity of Dipeptidyl peptidase-IV enzyme) after repeated administrations of sitagliptin 25, 50 and 100 mg
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration
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 23 Feb 2011.
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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.
Kyung-Sang Yu, MD, PhD principal investigator
Seoul National University College of Medicine and Hospital
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 Sitagliptin in people with Diabetes Mellitus, run by Seoul National University Hospital 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 13 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 23 Feb 2011. 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?
To evaluate the pharmacokinetics after repeated administrations of sitagliptin 25, 50 and 100 mg (time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration). 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 23 Feb 2011.