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

ISRCTN ISRCTN32485300
DOI https://doi.org/10.1186/ISRCTN32485300
Protocol serial number 583001.01.103
Sponsor Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Funder Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Submission date
06/05/2010
Registration date
11/06/2010
Last edited
28/06/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Fathi Abdul Malek
Scientific

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

Study information

Primary study designInterventional
Study designPhase I single centre double blind randomised placebo controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA 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
Study objectivesTo 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(s)Added 28/06/10:
Medical Research Council approved on the 14th of June 2010 (ref: 4697-1/2010-1017EKL)
Health condition(s) or problem(s) studiedHealthy male volunteers
InterventionPriaculin 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date15/11/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target sample size at registration32
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment16/06/2010
Date of final enrolment15/11/2010

Locations

Countries of recruitment

  • Germany
  • Hungary

Study participating centre

Dr. Willmar Schwabe GmbH & Co. KG
Karlsruhe
76227
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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