Diabetes MellitusPhase 1NCT01901757
Single-dose, 2-way Crossover Open Study to Evaluate the Food Effect on the PK of HCP1201 in Healthy Volunteers
A Phase 1 study testing HCP1201, Fasted followed by fed and HCP1201, Fed followed by fasted in people with Diabetes Mellitus, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in fed versus fasted condition Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- HCP1201, Fasted followed by fed and HCP1201, Fed followed by fasted
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Jul 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer, age 20~55 years
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- Subject who has the ability and willingness to participate the whole period of trial
Who cannot join
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
- Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
- Systolic Blood Pressure: lower than 90mmHg or higher than 150mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 100mmHg
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
- History of drug abuse or positive drug screening.
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- Participation in other drug studies within 60days prior to the drug administration.
- Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
- Subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement)
- Subjects who took medicines(e.g. proton pump inhibitor, rifampicin, oriental medicines, etc.) within 30days that can affect absorption, distribution, metabolism, elimination of metformin/rosuvastatin.
- Intake of more than 140g of alcohol per week or who can't abstain from alcohol during the trial.
- Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial.
- Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV).
- Genetic myopathic disorder or related family history, medical history of myopathic disorder caused by medication.
- Clinically inappropriate laboratory test result.
- Clinically inappropriate electrocardiogram result.
- Subjects who judged ineligible by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of HCP1201 Tablet in Healthy Volunteers
To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in fed versus fasted condition
Read the detailed description
An open-label, randomized, single-dose crossover study to evaluate the effect of food on the pharmacokinetics of HCP1201 tablet in healthy volunteers
- Conditions
- Diabetes Mellitus
- Being tested
- HCP1201, Fasted followed by fed, HCP1201, Fed followed by fasted
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1201, Fasted followed by fedDrug
There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition.
HCP1201, Fed followed by fastedDrug
There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition.
| Study group | Role | What they receive |
|---|---|---|
| HCP1201, Fasted followed by fed | Experimental | HCP1201 dosing in the fasted state followed by fed dosing Receives: Drug: HCP1201, Fasted followed by fed; Drug: HCP1201, Fed followed by fasted |
| HCP1201, Fed followed by fasted | Experimental | HCP1201 dosing in the fed state followed by fasted dosing Receives: Drug: HCP1201, Fasted followed by fed; Drug: HCP1201, Fed followed by fasted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metformin, rosuvastatin Cmax, AUClast
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Secondary outcomes (5)
Metformin, rosuvastatin Tmax
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin T1/2
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin AUCinf
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin CL/F
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin Vd/F
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
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.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jung Ryul Kim, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901757
- Sponsor's protocol ID
- HM-MERO-102
- Status last verified
- Aug 2013
- First submitted
- 7 Jul 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of HCP1201 Tablet in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01901757
- Acronym / sponsor ID
- HM-MERO-102
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Jul 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.
To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in fed versus fasted condition
Detailed description
An open-label, randomized, single-dose crossover study to evaluate the effect of food on the pharmacokinetics of HCP1201 tablet in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCP1201, Fasted followed by fed | Experimental | Drug: HCP1201, Fasted followed by fed, Drug: HCP1201, Fed followed by fastedHCP1201 dosing in the fasted state followed by fed dosing |
| HCP1201, Fed followed by fasted | Experimental | Drug: HCP1201, Fasted followed by fed, Drug: HCP1201, Fed followed by fastedHCP1201 dosing in the fed state followed by fasted dosing |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteer, age 20~55 years
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- Subject who has the ability and willingness to participate the whole period of trial
Key exclusion criteria (17 listed)
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
- Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
- Systolic Blood Pressure: lower than 90mmHg or higher than 150mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 100mmHg
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
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 |
|---|---|---|
| HCP1201, Fasted followed by fedThere are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition. | Drug | HCP1201, Fasted followed by fed, HCP1201, Fed followed by fasted |
| HCP1201, Fed followed by fastedThere are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition. | Drug | HCP1201, Fasted followed by fed, HCP1201, Fed followed by fasted |
Primary outcome
Metformin, rosuvastatin Cmax, AUClast
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
5 secondary outcomes
Metformin, rosuvastatin Tmax
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin T1/2
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin AUCinf
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin CL/F
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin Vd/F
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
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 13 Aug 2013.
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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.
Jung Ryul Kim, M.D. principal investigator
Samsung Medical Center
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 HCP1201, Fasted followed by fed and HCP1201, Fed followed by fasted in people with Diabetes Mellitus, run by Hanmi Pharmaceutical Company Limited 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 17 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 13 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?
Metformin, rosuvastatin Cmax, AUClast (time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h). 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 13 Aug 2013.