Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
583001.01.103
Study information
Scientific title
A randomised, placebo-controlled, double-blind phase I study to assess the safety, tolerability and pharmacokinetics of repeated p. o. doses of 75 to 600 mg Priaculin in healthy male volunteers
Acronym
Study hypothesis
To investigate the safety, tolerability and pharmacokinetics of repeated once daily p. o. doses of 75 to 600 mg Priaculin in healthy male volunteers
Ethics approval
Added 28/06/10:
Medical Research Council approved on the 14th of June 2010 (ref: 4697-1/2010-1017EKL)
Study design
Phase I single centre double blind randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Healthy male volunteers
Intervention
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 22 days.
Group 2 starts after conclusion and data evaluation of group 1. During the treatment period the subjects are hospitalised in the study clinical unit from day -2 until day 24. The treatment period of each group is preceded by a screening visit for eligibility assessment. An end-of-trial safety follow-up visit is schedule within one week after day 24.
Intervention type
Other
Phase
Phase I
Drug names
Primary outcome measure
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 outcome measures
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
Overall trial start date
16/06/2010
Overall trial end date
15/11/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
32
Participant 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
Recruitment start date
16/06/2010
Recruitment end date
15/11/2010
Locations
Countries of recruitment
Hungary
Trial participating centre
Dr. Willmar Schwabe GmbH & Co. KG
Karlsruhe
76227
Germany
Sponsor information
Organisation
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Sponsor details
c/o Dr. F. A. Malek
Clinical Research Department
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list