Healthy white male participants were eligible for inclusion to the study if they were ≥ 40 years of age and ≤ 60 years of age and had a body mass index ≥ 18.0 kg/m2 and ≤ 29.9 kg/m2. Participants were excluded if they had a clinically relevant finding on the electrocardiogram (ECG), had systolic blood pressure (SBP) < 100 mmHg or > 145 mmHg, had diastolic blood pressure (DBP) < 60 mmHg or > 95 mmHg, or heart rate (HR) < 50 or > 95 beats per min (bpm). Regular use of medication within 4 weeks and any use of medication, herbal products, or vitamins within 14 days prior to the first study drug administration were prohibited. Regular daily consumption of more than ten cigarettes and intake of foods and beverages containing grapefruit within 14 days before study drug administration were exclusion criteria. A full list of inclusion and exclusion criteria is included in Table S1 of the Electronic Supplementary Material (ESM).
Protocol detail
Healthy Male Participant Eligibility
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Beverages
Body mass index
Diastolic blood pressure
Electrocardiogram
Foods intake
Grapefruit
Healthy participants
Heart rate
Male
Medication
Systolic blood pressure
Vitamins
Corresponding Organization :
Other organizations : Bayer (Germany), Clinical Research Services
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Variable analysis
independent variables
- None explicitly mentioned
- Clinically relevant finding on the electrocardiogram (ECG)
- Systolic blood pressure (SBP)
- Diastolic blood pressure (DBP)
- Heart rate (HR)
- Participant age (≥ 40 years and ≤ 60 years)
- Body mass index (≥ 18.0 kg/m^2 and ≤ 29.9 kg/m^2)
- Medication use (no regular use within 4 weeks and no use within 14 days prior to first study drug administration)
- Cigarette consumption (no regular daily consumption of more than ten cigarettes)
- Intake of foods and beverages containing grapefruit (none within 14 days before study drug administration)
- Negative control: Participants were excluded if they had clinically relevant findings on the electrocardiogram (ECG), systolic blood pressure (SBP) < 100 mmHg or > 145 mmHg, diastolic blood pressure (DBP) < 60 mmHg or > 95 mmHg, or heart rate (HR) < 50 or > 95 beats per min (bpm).
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