A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group desig

• Conditions: Caucasian males aged between 18 and 50 years of age (inclusive) with cystic fibrosis and pancreatic insufficiency able to discontinue their standard pancreatic enzyme therapy during the treatment phase of the study.; MedDRA version: 8.1Level: LLTClassification code 10011762Term: Cystic fibrosis

• Registration Number: EUCTR2006-005180-25-DE
• Lead Sponsor: ordmark Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1. Able to understand and follow instructions during the study.
2. Signed informed consent.
3. Caucasian male patients aged between 18 and 50 years with CF transmembrane conductance regulator mutations on both alleles or two positive sweat tests, with pancreas insufficiency who are able to discontinue their standard pancreatic enzyme therapy during the treatment phase of the study (i.e., Study Days 2-4).
4. Pancreatic elastase E1 < 200 ?g/g in stool at screening,
5. General good physical health as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory tests.
6. Weight within the normal range according to accepted values for the Body mass index (BMI) within 18.5-29.9 kg/m2.
7. Normal blood pressure (Systolic Blood Pressure (SBP) >95, <139 mmHg; Diastolic Blood Pressure (DBP) >55, <90 mmHg) measured after 5 min rest in supine position.
8. A heart rate at rest of >45 and <99 b/min measured after 5 min rest in supine position.
9. ECG recording without clinically significant abnormalities.
10. Having had no febrile or infectious illness for at least seven days prior to the first administration of the IMPs of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Acute exacerbations of CF.
2. History of infection with burkholderia cepacia (B. cepacia) or methicillin-resistant staphylococcus aureus within the last six months.
3. Clinically not acceptable lung function, as determined by FEV1 (Forced Expiratory Volume in one second) < 40% predicted
4. Distal Intestinal Obstruction Syndrome within the past 12 months.
5. Oral antacid therapy with H2-antagonists or proton pump inhibitors within the past 3 months.
6. Systemic corticosteroids within the past 3 months.
7. Positive test for human immunodeficiency virus (HIV) antibodies.
8. Positive hepatitis-B-virus-surface antigen (HBsAg) test.
9. Positive Anti-hepatitis-C-virus antibodies (Anti-HCV) test.
10. Laboratory values suggesting an unknown disease in the opinion of the investigator and/or requiring further clinical evaluation assessed by the investigator (especially ALT, aspartate aminotransferase (AST), gamma glutamyltranspeptidase (GGT)).
11. Any history of alcohol or drug abuse.
12. More than moderate alcohol consumption (>35 g of ethanol regularly per day or >245 g regularly per week).
13. Ethanol consumption within 48 hours prior to administration verified by alcohol breath test (Alcotest®).
14. Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis abuse (verified by Mahsan Kombi/DOA2- and Mahsan Kombi4/O2T Schnelltest).
15. More than moderate smoker (>10 cigarettes/day).
16. Demonstrating excess in xanthine consumption (more than five cups of coffee or equivalent per day).
17. Any history of drug hypersensitivity that is assessed to be of clinical relevance, asthma, urticaria or other severe allergic diathesis.
18. Any history of hypersensitivity to the IMP.
19. Any disease state – other than CF – that, in the opinion of the investigator, does not allow study participation.
20. Participation in the treatment phase of a clinical study within 30 days prior to the treatment phase of this study.
21. Blood donation within 30 days prior to inclusion in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified