Healthy Male IndividualsPhase 1NCT02817932
A Study of Pharmacokinetics and Safety of Ranolazine PR in Healthy Korean and Caucasian Male Subjects
A Phase 1 study testing Ranolazine in people with Healthy Male Individuals, run by A.Menarini Asia-Pacific Holdings Pte Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is: To assess the pharmacokinetic profile and safety of ranolazine PR in healthy Korean and Caucasian volunteers after oral administration of Ranolazine at the doses of 375, 500, 750mg after single and repeated oral administrations. 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
- Healthy Male Individuals
- What is being tested?
- Ranolazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Oct 2016
- 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 adult Korean or Caucasian males, 19 - 45 years of age
- Korean subjects: first generation of Korean subject born in Korea, both parents and the four grandparents must be of Korean origin. Proof of Korean ethnicity will be documented by medical interview and appropriate materials (e.g. Korean passport, Korean resident card) will be retained in the subject's folder
- Caucasian subjects: first generation of Caucasian subject, both parents and the four grandparents of European descent. Documentation of ethnicity will be by medical interview and by appropriate materials (e.g. passport, birth certificate(if not available, a signed affirmation by the subjects)) will be retained in the subject's folder
- Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit
- Subjects with no clinically significant abnormal findings as determined by physical examination, ECG, medical history, or clinical laboratory test results
- Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study
Who cannot join
- History of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
- Relevant chronic or acute infections
- History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
- Administration of any investigational products within 3 months from the first dose of the study drug (ranolazine PR)
- History of participating other BE study or clinical trial within 3 months from the first dose of the study drug(ranolazine PR)
Show all 22Show fewer
- Any of the following vital sign abnormalities
- Systolic blood pressure: <90 mmHg or >140 mmHg
- Diastolic blood pressure: <50 mmHg or > 90 mmHg
- Pulse rate: <50 bpm or >90 bpm
- Any of the following ECG abnormalities
- PR > 210 msec
- QRS complex > 120 msec
- QTcF > 430 msec
- Any finding in the physical examination deviating from normal and judged clinically significant by the investigator
- Any laboratory value outside of the reference range that the investigator considers to be of clinical significance
- Subjects who have donated blood or received blood transfusion within 90 days of participating in this study
- Subjects who are positive for Hepatitis B, Hepatitis C, VDRL and HIV
- Subjects who showed positive result in alcohol and drug abuse tests
- Subjects who have smoked over 10 cigarettes until 90 days prior to the study initiation or who is not able to stop smoking throughout the hospitalization period
- Subjects who took prescribed medications within 14 days or over-the-counter (OTC) medications within 7 days prior to the first dose of the study drug (ranolazine PR) or who have to take these medications during the study period
- Subject who judged not eligible for study participation by investigator
Trial locations and contacts
1 site in 1 country.
In-Jin Jang, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
In-Jin Jang, MD, +82 2 2072 1910
About this study
Official title: A Single-center, Open-label, Ascending Single- and Multiple-oral Dose Study to Evaluate the Pharmacokinetics and Safety of Ranolazine PR in Healthy Korean and Caucasian Male Subjects
The purpose of this study is:
To assess the pharmacokinetic profile and safety of ranolazine PR in healthy Korean and Caucasian volunteers after oral administration of Ranolazine at the doses of 375, 500, 750mg after single and repeated oral administrations.
Read the detailed description
Ranolazine is an antianginal drug that exerts its effects by inhibition of the late sodium current in cardiac cells. This action reduces intracellular sodium accumulation and consequently decreases intracellular calcium overload which is expected to reduce myocardial stiffness, oxygen consumption and ATP utilization and improve blood flow to the microvasculature.These effects of ranolazine do not depend upon reductions in heart rate or blood pressure or vasodilation.
Ranolazine PR, approved for treatment of chronic angina in 56 countries and currently marketed in 21 countries including the US shows clinical efficacy and tolerability in the proposed therapeutic dose range from 375 mg to 750mg. Factors that may affect ranolazine pharmacokinetics including demographics, drug-drug interactions, disease state, CYP2D6 metabolizer genotype status and impaired renal or hepatic functions have been studied. The relationship between ranolazine plasma concentration and clinical effects has been also well-established. This PK study has been designed as a bridging study for Ranolazine PR registration in Korea.
- Conditions
- Healthy Male Individuals
- Being tested
- Ranolazine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Korean, 375 mg) | Experimental | Group 1 (Korean, 375 mg): Ranolazine PR 375 mg Receives: Drug: Ranolazine |
| Group 2 (Korean, 500 mg): | Experimental | Group 2 (Korean, 500 mg): Ranolazine PR 500 mg Receives: Drug: Ranolazine |
| Group 3 (Korean, 750 mg): | Experimental | Group 3 (Korean, 750 mg): Ranolazine PR 750 mg Receives: Drug: Ranolazine |
| Group 4 (Caucasian, 375mg) | Experimental | Group 4 (Caucasian, 375mg) : Ranolazine PR 375 mg Receives: Drug: Ranolazine |
| Group 5 (Caucasian, 750mg) | Experimental | Group 5 (Caucasian, 750mg) : Ranolazine PR 750 mg Receives: Drug: Ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessment
Area under the plasma concentration versus time curve (AUC)
Measured: Up to 5 days
Pharmacokinetic Assessment
Plasma concentration (maximum,through, average)
Measured: Up to 5 days
Pharmacokinetic Assessment
Tmax
Measured: Up to 5 days
Pharmacokinetic Assessment
Half-life
Measured: Up to 5 days
Secondary outcomes (1)
Number of participants with treatment-related adverse events assessed using MedDRA
Assessment based on reported symptoms, physical examination, vital signs, adverse events, ECGs, laboratory test results
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Male IndividualsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.Menarini Asia-Pacific Holdings Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817932
- Sponsor's protocol ID
- MAKR/15/Ran-Ang/001
- Status last verified
- Jun 2016
- First submitted
- 29 Apr 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yoo H, Lee SW, Yoon DY, Yoon SH, Cho JY, Yu KS, Jang IJ, Lee S. Pharmacokinetics and Safety of Extended-release Ranolazine in Korean and White Healthy Subjects. Clin Ther. 2021 Mar;43(3):526-534.e4. doi: 10.1016/j.clinthera.2021.01.005. Epub 2021 Jan 29.
PubMed 33518355
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Ascending Single- and Multiple-oral Dose Study to Evaluate the Pharmacokinetics and Safety of Ranolazine PR in Healthy Korean and Caucasian Male Subjects
- ClinicalTrials.gov ID
- NCT02817932
- Acronym / sponsor ID
- MAKR/15/Ran-Ang/001
- Conditions
- Healthy Male Individuals
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- A.Menarini Asia-Pacific Holdings Pte LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 29 Jun 2016 (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 assess the pharmacokinetic profile and safety of ranolazine PR in healthy Korean and Caucasian volunteers after oral administration of Ranolazine at the doses of 375, 500, 750mg after single and repeated oral administrations.
Detailed description
Ranolazine is an antianginal drug that exerts its effects by inhibition of the late sodium current in cardiac cells. This action reduces intracellular sodium accumulation and consequently decreases intracellular calcium overload which is expected to reduce myocardial stiffness, oxygen consumption and ATP utilization and improve blood flow to the microvasculature.These effects of ranolazine do not depend upon reductions in heart rate or blood pressure or vasodilation.
Ranolazine PR, approved for treatment of chronic angina in 56 countries and currently marketed in 21 countries including the US shows clinical efficacy and tolerability in the proposed therapeutic dose range from 375 mg to 750mg. Factors that may affect ranolazine pharmacokinetics including demographics, drug-drug interactions, disease state, CYP2D6 metabolizer genotype status and impaired renal or hepatic functions have been studied. The relationship between ranolazine plasma concentration and clinical effects has been also well-established. This PK study has been designed as a bridging study for Ranolazine PR registration in Korea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Korean, 375 mg) | Experimental | Drug: RanolazineGroup 1 (Korean, 375 mg): Ranolazine PR 375 mg |
| Group 2 (Korean, 500 mg): | Experimental | Drug: RanolazineGroup 2 (Korean, 500 mg): Ranolazine PR 500 mg |
| Group 3 (Korean, 750 mg): | Experimental | Drug: RanolazineGroup 3 (Korean, 750 mg): Ranolazine PR 750 mg |
| Group 4 (Caucasian, 375mg) | Experimental | Drug: RanolazineGroup 4 (Caucasian, 375mg) : Ranolazine PR 375 mg |
| Group 5 (Caucasian, 750mg) | Experimental | Drug: RanolazineGroup 5 (Caucasian, 750mg) : Ranolazine PR 750 mg |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult Korean or Caucasian males, 19 - 45 years of age
- Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit
- Subjects with no clinically significant abnormal findings as determined by physical examination, ECG, medical history, or clinical laboratory test results
- Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study
Key exclusion criteria (22 listed)
- History of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
- Relevant chronic or acute infections
- History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
- Administration of any investigational products within 3 months from the first dose of the study drug (ranolazine PR)
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 |
|---|---|---|
| Ranolazine | Drug | Group 1 (Korean, 375 mg), Group 2 (Korean, 500 mg):, Group 3 (Korean, 750 mg):, Group 4 (Caucasian, 375mg), Group 5 (Caucasian, 750mg) |
Primary outcome
Pharmacokinetic assessment
Time frame: Up to 5 days
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic Assessment
Time frame: Up to 5 days
Plasma concentration (maximum,through, average)
Pharmacokinetic Assessment
Time frame: Up to 5 days
Tmax
Pharmacokinetic Assessment
Time frame: Up to 5 days
Half-life
1 secondary outcome
Number of participants with treatment-related adverse events assessed using MedDRA
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Derived from this study: PubMed 33518355Yoo H, Lee SW, Yoon DY, Yoon SH, Cho JY, Yu KS, Jang IJ, Lee S. Pharmacokinetics and Safety of Extended-release Ranolazine in Korean and White Healthy Subjects. Clin Ther. 2021 Mar;43(3):526-534.e4. doi: 10.1016/j.clinthera.2021.01.005. Epub 2021 Jan 29.
- Individual participant dataSharing planned: No
Related trials for Healthy Male Individuals
Enrolling by invitationObservational study
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Effects of Walking and Cycling on Serum Physiological Biomarkers
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.
In-Jin Jang, MD contact
In-Jin Jang, MD principal investigator
Seoul 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 Ranolazine in people with Healthy Male Individuals, run by A.Menarini Asia-Pacific Holdings Pte Ltd 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 6 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 29 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact In-Jin Jang, MD (: +82 2 2072 1910), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic assessment (time frame: Up to 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02817932, which also lists 1 linked publication.
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 29 Jun 2016.