Healthy male volunteers Not Applicable
Conditions
Interventions
Priaculin film coated tablets (stepwise increasing doses from 75 mg to 150 mg to 300 mg for group 1 and from 300 mg to 450 mg to 600 mg for group 2) or placebo film coated tablets p. o. once daily for
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male 2. Caucasian 3. Age 30 - 55 years (included) 4. BMI between 18 and 26 kg/m2 5. Healthy on the basis of extensive pre-study investigation 6. Willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Previous participation in the present trial 2. Participation in any other trial during the last 90 days 3. Donation of blood or plasma within the last 90 days before recruitment 4. History of any clinically relevant allergy 5. Presence of acute or chronic infection 6. Subjects with history or present conditions of clinically relevant cardiovascular, urogenital, gastrointestinal, hepatic, metabolic, endocrine, neurological or psychiatric abnormalities, defined in the clinical trial protocol 7. Presence or history of regular/habitual diarrhoea or constipation 8. Resting supine systolic blood pressure (SBP) > 140 or 95 or 100 bpm 10. Drop in SBP upon one minute relaxed upright standing (orthostatic challenge) by > 25 mmHg, or symptoms of faintness or dizziness on standing irrespective of the extent of standing blood pressure reduction 11. ECG-abnormalities: AV-block (AV-block grade I included), QT-interval >= 480 msec, QTc-interval (Bazett) >= 450 msec, sick-sinus syndrome 12. Subjects with relevant abnormalities in the clinical laboratory tests, defined in the clinical trial protocol 13. History of alcohol or (social) drug abuse 14. Positive alcohol or urine drug test 15. Daily consumption of > 30 g alcohol 16. Smoking more than 10 cigarettes/day or equivalent of other tobacco products or having done so within the last 6 months prior to inclusion into the study 17. Use of confounding medication 18. Suspicion or evidence that the subject is not reliable 19. Suspicion or evidence that the subject is not able to make a free consent or to understand the information detailed in the subject information sheet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability 1. Wellbeing and adverse events checked daily 2. Cardiovascular safety checked daily 3. Clinical laboratory tests at screening, on day -1, 8, 15, 22 and within one week after the last clinical visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacodynamic safety parameters 1.1. Blood pressure measured daily 1.2. Pulse rate measured daily 1.3. ECG performed at screening, on days -1, 1, 8, 15, 22 and within one week after the last clinical visit 2. Plasma pharmacokinetics assessed on day 1, 8, 15 and 22-24 | — |
Countries
Hungary
Outcome results
None listed