Evaluation of the safety, tolerability and pharmacokinetics of repeated oral doses of Priaculin in healthy male volunteers

Completed

• Conditions: Healthy male volunteers; Not Applicable

• Registration Number: ISRCTN32485300
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 32

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

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 < 100 mmHg, resting supine diastolic blood pressure (DBP) > 95 or < 60 mmHg
9. Resting pulse (PR) or electrocardiographic heart rate (HR) < 50 bpm 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability <br>1. Wellbeing and adverse events checked daily<br>2. Cardiovascular safety checked daily<br>3. Clinical laboratory tests at screening, on day -1, 8, 15, 22 and within one week after the last clinical visit

Secondary Outcome Measures

Name	Time	Method
1. Pharmacodynamic safety parameters <br>1.1. Blood pressure measured daily<br>1.2. Pulse rate measured daily<br>1.3. ECG performed at screening, on days -1, 1, 8, 15, 22 and within one week after the last clinical visit<br>2. Plasma pharmacokinetics assessed on day 1, 8, 15 and 22-24