- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01804010
Pharmacokinetic, Pharmacodynamic Profiles and Safety After Oral Administration of Ivabradine in Male Healthy Korean Volunteers
- To assess the pharmacokinetic profile of ivabradine (S 16257) and its main active metabolite S 18982 in Korean healthy volunteers after oral administration of ivabradine at the doses of 2.5, 5, 10mg and after repeated oral administrations of ivabradine for 4.5 days at the same doses twice daily versus placebo and to use the study results for bridging with Caucasian data.
- The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on heart rate after single and then after repeated administrations.
- Clinical safety of ivabradine versus placebo.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 138-736
- Asan Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18 and 40 years and Korean
- Nonsmoker or smoke less than 5 cigarettes per day
- normal dietary habits
- BMI ranging from 18 to 25 kg/m2
- good physical and mental status, determined by the investigator
- vital signs in resting condition within range: SBP 100-139 mmHg, DBP 50-89 mmHg
- Normal ECG
Exclusion Criteria:
- Participate any other trial in the last 3 months prior to the study
- History of major psychiatric, medical, surgical disorders
- Acute, or chronic disease
- History of hypersensitivity to at least one drug
- History of alcoholism or positive alcohol breath test
- Positive drug screening results
- known positive serology for HIV1, HIV2, hepatitis B or C
- blood donor within the last 3 month of the study
- regular use of sedatives, hypnotics, tranquillisers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo administration
|
Single and repeated oral administrations of 3 doses of ivabradine (2.5, 5, and 10 mg).
Subjects were given a single administration of ivabradine during Period 1 (P1), following a 3-day washout, they were given repeated administrations twice daily for 4.5 days during Period 2 (P2).
Other Names:
|
Active Comparator: Ivabradine
Single and repeated oral administrations of 3 doses of ivabradine
|
Single and repeated oral administrations of 3 doses of ivabradine (2.5, 5, and 10 mg).
Subjects were given a single administration of ivabradine during Period 1 (P1), following a 3-day washout, they were given repeated administrations twice daily for 4.5 days during Period 2 (P2).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax,tmax, AUC(Area under the time-concentration curve) of ivabradine and metabolite
Time Frame: within 60 days after blood sampling (blood sample analysis)
|
For PK measurements, blood samplings were done: pre-dose then 20 min, 40 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h, 60 h, and 72 h following the D1 single administration (P1) and the Day 8 (D8) last repeated dose (P2), respectively.Ivabradine and its main metabolite were determined using LC-MS/MS, then pharmacokinetic parameters were calculated by noncompartmental approach.
Descriptive statistics were performed on the PK individual parameters calculated from the plasma concentration-time profiles.
|
within 60 days after blood sampling (blood sample analysis)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pharmacodynamics: The change of heart rate between baseline and over 24-hour, diurnal, nocturnal, awake, and asleep periods after administration of ivabradine
Time Frame: within 10 days after administration
|
For PD measurements, 24-hour Holter recordings were performed on Day0, Day1, Day8, and Day10. a resting 12-lead ECG were also performed. The changes of heart rate between day 1 and baseline values, between day 8 and baseline values were studied over 24-hour, diurnal, nocturnal, awake and asleep period for each ivabradine dose in comparison with placebo. Descriptive statistics by dose were performed and confidence intervals of the differences between each dose of ivabradine and placebo were constructed using a non-parametric method based on Hodges & Lehman estimate for independent samples. |
within 10 days after administration
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2007-0114
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