Stepwise ascending single-dose tolerability of Dulamin

ISRCTN ISRCTN23790710
DOI https://doi.org/10.1186/ISRCTN23790710
Protocol serial number 561501.01.001
Sponsor Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Funder Dr. Willmar Schwabe GmbH & Co. KG (Germany)
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

Weyertal 76
Cologne
50931
Germany

Study information

Primary study designInterventional
Study designSingle centre, randomised, double-blind, placebo-controlled, dose-escalation study with oral single dose administration.
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA 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 objectivesThe 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) studiedSafety of Dulamin
InterventionSingle doses of 150 mg, 300 mg, 600 mg, 1200 mg, 1800 mg and 2400 mg Dulamin or placebo
Intervention typeDrug
PhasePhase I
Drug / device / biological / vaccine name(s)Dulamin
Primary outcome measure(s)

1. Adverse events
2. Laboratory data
3. Blood pressure
4. Pulse rate
5. Electrocardiogram

Key secondary outcome measure(s)

Plasma pharmacokinetics

Completion date23/01/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target sample size at registration24
Key inclusion criteria1. 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 criteria1. 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 enrolment04/10/2011
Date of final enrolment23/01/2012

Locations

Countries of recruitment

  • Germany

Study participating centre

Weyertal 76
Cologne
50931
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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