Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/08/2011
Date assigned
02/09/2011
Last edited
11/10/2011
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

Prof Uwe Fuhr

ORCID ID

Contact details

Weyertal 76
Cologne
50931
Germany

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

http://www.schwabepharma.com/

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

Publication citations

Additional files

Editorial Notes