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

NCT ID: NCT01804010

Last Updated: 2013-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2007-11-30

Brief Summary

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.

Conditions

Healthy Individual

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ivabradine

Single and repeated oral administrations of 3 doses of ivabradine

Group Type: ACTIVE_COMPARATOR

Ivabradine and placebo

Intervention Type: 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).

Placebo

Placebo administration

Group Type: PLACEBO_COMPARATOR

Ivabradine and placebo

Intervention Type: 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).

Interventions

Ivabradine and placebo

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).

Intervention Type: DRUG

Other Intervention Names

Ivabradine; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institut de Recherches Internationales Servier

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kyun-Seop Bae

Dep. of clinical pharmacology and therapeutics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyun-Seop Bae, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

2007-0114

Identifier Type: -

Identifier Source: org_study_id