Healthy Male VolunteersPhase 1NCT03532854
Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802
A Phase 1 study testing Valsartan and Ezetimibe/Rosuvastatin in people with Healthy Male Volunteers, run by LG Chem at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Valsartan and Ezetimibe/Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2018to 30 Jan 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male
- Age between 19 and 50
- Subjects with BMI of 18~27 kg/m2 with a weight of 55kg or more
- Subjects with SBP of 90~150 mmHg and DBP of 60~150 mmHg
- Signed informed consent
Who cannot join
- Presence of medical history or a concurrent disease
- Has a history of hypersensitivity to IP ingredients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between LGEV1801 and LGEV1802 in Healthy Korean Male Volunteers
The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.
- Conditions
- Healthy Male Volunteers
- Being tested
- Valsartan, Ezetimibe/Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Also called Diovan
Valsartan P.O
Ezetimibe/RosuvastatinDrug
Also called Rosuzet
Ezetimibe/Rosuvastatin P.O
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Ezetimibe/Rosuvastatin -> Valsartan -> Valsartan and Ezetimibe/Rosuvastatin Receives: Drug: Valsartan; Drug: Ezetimibe/Rosuvastatin |
| Sequence B | Experimental | Valsartan -> Valsartan and Ezetimibe/Rosuvastatin-> Ezetimibe/Rosuvastatin Receives: Drug: Valsartan; Drug: Ezetimibe/Rosuvastatin |
| Sequence C | Experimental | Valsartan and Ezetimibe/Rosuvastatin -> Ezetimibe/Rosuvastatin -> Valsartan Receives: Drug: Valsartan; Drug: Ezetimibe/Rosuvastatin |
| Sequence D | Experimental | Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin-> Valsartan Receives: Drug: Valsartan; Drug: Ezetimibe/Rosuvastatin |
| Sequence E | Experimental | Valsartan -> Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin Receives: Drug: Valsartan; Drug: Ezetimibe/Rosuvastatin |
| Sequence F | Experimental | Valsartan and Ezetimibe/Rosuvastatin -> Valsartan -> Ezetimibe/Rosuvastatin Receives: Drug: Valsartan; Drug: Ezetimibe/Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCT,ss
Measured: Day 1~Day 8
Cmax,ss
Measured: Day 1~ Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start28 May 2018
- Primary completion25 Aug 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532854
- Sponsor's protocol ID
- LG-EVCL001
- Status last verified
- Feb 2019
- First submitted
- 8 May 2018
- Last updated
- 15 Feb 2019
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between LGEV1801 and LGEV1802 in Healthy Korean Male Volunteers
- ClinicalTrials.gov ID
- NCT03532854
- Acronym / sponsor ID
- LG-EVCL001
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 28 May 2018 (actual)
- Primary completion
- 25 Aug 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 22 May 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.
The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Valsartan, Drug: Ezetimibe/RosuvastatinEzetimibe/Rosuvastatin -> Valsartan -> Valsartan and Ezetimibe/Rosuvastatin |
| Sequence B | Experimental | Drug: Valsartan, Drug: Ezetimibe/RosuvastatinValsartan -> Valsartan and Ezetimibe/Rosuvastatin-> Ezetimibe/Rosuvastatin |
| Sequence C | Experimental | Drug: Valsartan, Drug: Ezetimibe/RosuvastatinValsartan and Ezetimibe/Rosuvastatin -> Ezetimibe/Rosuvastatin -> Valsartan |
| Sequence D | Experimental | Drug: Valsartan, Drug: Ezetimibe/RosuvastatinEzetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin-> Valsartan |
| Sequence E | Experimental | Drug: Valsartan, Drug: Ezetimibe/RosuvastatinValsartan -> Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin |
| Sequence F | Experimental | Drug: Valsartan, Drug: Ezetimibe/RosuvastatinValsartan and Ezetimibe/Rosuvastatin -> Valsartan -> Ezetimibe/Rosuvastatin |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male
- Age between 19 and 50
- Subjects with BMI of 18~27 kg/m2 with a weight of 55kg or more
- Subjects with SBP of 90~150 mmHg and DBP of 60~150 mmHg
- Signed informed consent
Key exclusion criteria (2 listed)
- Presence of medical history or a concurrent disease
- Has a history of hypersensitivity to IP ingredients
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 |
|---|---|---|
| ValsartanAlso: DiovanValsartan P.O | Drug | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
| Ezetimibe/RosuvastatinAlso: RosuzetEzetimibe/Rosuvastatin P.O | Drug | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
Primary outcome
AUCT,ss
Time frame: Day 1~Day 8
Cmax,ss
Time frame: Day 1~ Day 8
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 15 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Healthy Male Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
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 Valsartan and Ezetimibe/Rosuvastatin in people with Healthy Male Volunteers, run by LG Chem 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 2 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 15 Feb 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?
AUCT,ss (time frame: Day 1~Day 8). 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 15 Feb 2019.