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Completed

NCT Number: NCT01804010

Pharmacokinetic, Pharmacodynamic Profiles and Safety After Oral Administration of Ivabradine in Male Healthy Korean Volunteers

1. 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. 2. The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on heart rate after single and then after repeated administrations. 3. Clinical safety of ivabradine versus placebo.

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Key information

Conditions

Healthy Individual

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivabradine and placebo

Drug

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: Ivabradine, Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Institut de Recherches Internationales Servier

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 5, 2013
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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