Condition category
Not Applicable
Date applied
06/05/2010
Date assigned
11/06/2010
Last edited
28/06/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fathi Abdul Malek

ORCID ID

Contact details

Dr. Willmar Schwabe GmbH & Co. KG
Clinical Research Department
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany

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 measures

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

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

http://www.schwabepharma.com/international/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes