Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
561501.01.001
Study information
Scientific title
A stepwise sequential dose-rising phase I study to assess the safety and tolerability of single p.o of 150mg to 2400 mg Dulamin in healthy subjects
Acronym
Study hypothesis
The aim of this study is to evaluate the safety and tolerability of single p.o. doses of 150-2400mg Dulamin in healthy subjects
Ethics approval
Ethics Committee, Medical Association of North Rhine, [Ethik-Kommission der Ärztekammer Nordrhein], 10 October 2011, ref: 2011311
Study design
Single centre, randomised, double-blind, placebo-controlled, dose-escalation study with oral single dose administration.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Safety of Dulamin
Intervention
Single doses of 150 mg, 300 mg, 600 mg, 1200 mg, 1800 mg and 2400 mg Dulamin or placebo
Intervention type
Drug
Phase
Phase I
Drug names
Dulamin
Primary outcome measures
1. Adverse events
2. Laboratory data
3. Blood pressure
4. Pulse rate
5. Electrocardiogram
Secondary outcome measures
Plasma pharmacokinetics
Overall trial start date
04/10/2011
Overall trial end date
23/01/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18 - 55 years
2. Male
3. Caucasian
4. Informed consent
5. Healthy
6. Body mass index between 18 and 30 kg/m²
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
24
Participant exclusion criteria
1. History or current evidence of clinically relevant allergies
2. History or current evidence of any clinically relevant diseases suspected to influence PKs of the IMP or safety of the subjects:
2.1. Cardiovascular
2.2. Pulmonary
2.3. Hepatic
2.4. Renal
2.5. Gastrointestinal
2.6. Haematological
2.7. Endocrinological
2.8. Metabolic
2.9. Neurological
2.10. Psychiatric
3. History of malignancy
4. Febrile or infectious illness within 5 days prior to administration of IMP
5. Chronic or clinically relevant acute infections
6. Proneness to orthostatic dysregulation, fainting, or blackouts
7. Positive results in any of the virology tests for:
7.1. HIV I and II-antibody (Ab)
7.2. Hepatitis B surface antigen (HbsAg)
7.3. Anti-HBV capsid (Hbc) immune globulins (Ig) (IgG + IgM)
7.4. HCV-Ab
8. Positive illicit drug screen
9. Positive alcohol breath test
10. Clinically relevant history or current evidence for abuse of alcohol ( > 50 g/day ethanol) or drugs
11. Treatment with any agent known to induce/inhibit xenobiotic metabolising enzyme or transporter within 2 weeks prior to or during the study
12. Use of any medication (incl. over-the-counter medication) within 2 weeks before study drug administration or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment period
13. Consumption of any enzyme inducing or inhibiting aliments and beverages (e.g. broccoli, brussel sprout, grapefruit, grapefruit juice, St. John's Wort, star fruit etc.) within 72 hours prior to the start of the study
14. Consumption of any caffeine- or methylxanthine-containing product within 48 hours prior to the administration of IMP
15. Consumption of any flavonoid-containing product within 72 hours prior to the administration of IMP
16. Subjects with diseases or surgery of the gastrointestinal tract, which may interfere with drug absorption
17. Participation in drug studies within the last 30 days before administration of the IMP in the present study
18. Blood donation within the last 30 days before start of the study
19. Lack of ability or willingness to give informed consent
20. Vulnerable subjects (e.g. persons kept in detention)
Recruitment start date
04/10/2011
Recruitment end date
23/01/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Weyertal 76
Cologne
50931
Germany
Sponsor information
Organisation
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Sponsor details
Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
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