Stepwise ascending single-dose tolerability of Dulamin
| ISRCTN | ISRCTN23790710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23790710 |
| Secondary identifying numbers | 561501.01.001 |
- Submission date
- 18/08/2011
- Registration date
- 02/09/2011
- Last edited
- 11/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Prof Uwe Fuhr
Scientific
Scientific
Weyertal 76
Cologne
50931
Germany
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethics Committee, Medical Association of North Rhine, [Ethik-Kommission der Ärztekammer Nordrhein], 10 October 2011, ref: 2011311 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Dulamin |
| Primary outcome measure | 1. Adverse events 2. Laboratory data 3. Blood pressure 4. Pulse rate 5. Electrocardiogram |
| Secondary outcome measures | Plasma pharmacokinetics |
| Overall study start date | 04/10/2011 |
| Completion date | 23/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 24 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 04/10/2011 |
| Date of final enrolment | 23/01/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Weyertal 76
Cologne
50931
Germany
50931
Germany
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Research organisation
Research organisation
Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany
| Website | http://www.schwabepharma.com/ |
|---|---|
"ROR" |
https://ror.org/043rrkc78 |
Funders
Funder type
Research organisation
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
