DyslipidemiaPhase 1NCT03235362
A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706
A Phase 1 study testing YHR1705, YHR1706 and YHR1705+YHR1706 in people with Dyslipidemia and Type 2 Diabetes Mellitus, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Type 2 Diabetes Mellitus
- What is being tested?
- YHR1705, YHR1706 and YHR1705+YHR1706
- 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 siteSouth Korea
- Study dates
- 7 Aug 2017to 19 Sep 2017
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Who cannot join
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- Administration of other investigational products within 3 months prior to the first dosing
- Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-label, Multiple-dose, 3-treatment, 6-sequence, 3-period Crossover Clinical Trial to Investigate the Safety and Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706 in Healthy Volunteers
This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers
Read the detailed description
This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive days. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.
- Conditions
- Dyslipidemia, Type 2 Diabetes Mellitus
- Being tested
- YHR1705, YHR1706, YHR1705+YHR1706
- Medical subject headings
- Dyslipidemias, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHR1705Drug
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.
YHR1706Drug
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.
YHR1705+YHR1706Drug
Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3. Receives: Drug: YHR1705; Drug: YHR1706; Drug: YHR1705+YHR1706 |
| 2 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3. Receives: Drug: YHR1705; Drug: YHR1706; Drug: YHR1705+YHR1706 |
| 3 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3. Receives: Drug: YHR1705; Drug: YHR1706; Drug: YHR1705+YHR1706 |
| 4 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.
There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period. Receives: Drug: YHR1705; Drug: YHR1706; Drug: YHR1705+YHR1706 |
| 5 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3. Receives: Drug: YHR1705; Drug: YHR1706; Drug: YHR1705+YHR1706 |
| 6 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1.
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2.
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3. Receives: Drug: YHR1705; Drug: YHR1706; Drug: YHR1705+YHR1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
YHR1705, YHR1706 AUCtau
AUCtau
Measured: 0 - 24hours
YHR1705, YHR1706 Css, max
Css,max
Measured: 0 - 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start7 Aug 2017
- Primary completion19 Sep 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingul Kim, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235362
- Sponsor's protocol ID
- YH14755-103
- Status last verified
- Jul 2017
- First submitted
- 25 Jul 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Multiple-dose, 3-treatment, 6-sequence, 3-period Crossover Clinical Trial to Investigate the Safety and Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03235362
- Acronym / sponsor ID
- YH14755-103
- Conditions
- Dyslipidemia, Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 1 Aug 2017 (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.
This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers
Detailed description
This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive days. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: YHR1705, Drug: YHR1706, Drug: YHR1705+YHR17065 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3. |
| 2 | Experimental | Drug: YHR1705, Drug: YHR1706, Drug: YHR1705+YHR17065 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3. |
| 3 | Experimental | Drug: YHR1705, Drug: YHR1706, Drug: YHR1705+YHR17065 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3. |
| 4 | Experimental | Drug: YHR1705, Drug: YHR1706, Drug: YHR1705+YHR17065 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period. |
| 5 | Experimental | Drug: YHR1705, Drug: YHR1706, Drug: YHR1705+YHR17065 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3. |
| 6 | Experimental | Drug: YHR1705, Drug: YHR1706, Drug: YHR1705+YHR17065 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Key exclusion criteria (4 listed)
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- Administration of other investigational products within 3 months prior to the first dosing
- Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
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 |
|---|---|---|
| YHR1705Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period. | Drug | 1, 2, 3, 4, 5, 6 |
| YHR1706Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period. | Drug | 1, 2, 3, 4, 5, 6 |
| YHR1705+YHR1706Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period. | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
YHR1705, YHR1706 AUCtau
Time frame: 0 - 24hours
AUCtau
YHR1705, YHR1706 Css, max
Time frame: 0 - 24hours
Css,max
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 1 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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.
Mingul Kim, MD principal investigator
Chonbuk National University 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 YHR1705, YHR1706 and YHR1705+YHR1706 in people with Dyslipidemia and Type 2 Diabetes Mellitus, run by Yuhan Corporation 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 3 inclusion and 4 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 1 Nov 2017. 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?
YHR1705, YHR1706 AUCtau (time frame: 0 - 24hours). 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 1 Nov 2017.