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: 8.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Conditions
Interventions
Product Code: LU 70274
Pharmaceutical Form: Capsule*
Current Sponsor code: LU 70274
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 90000-
Pharmaceutical f
Sponsors
Nordmark Arzneimittel GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
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 95, 55, 45 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety, tolerability, and pharmacodynamics of multiple doses of LU 70274. To investigate the concentration of fat and lipase in stool. To investigate the intensity of abdominal pain and gastrointestinal discomfort. ;Secondary Objective: ;Primary end point(s): Safety and tolerability: Physical examination, vital signs, electrocardiogram (ECG), adverse events (AEs), subjective well-being, clinical chemistry, hematology, urine analysis, and overall tolerability, total immunoglobulin G (IgG) in serum. Pharmacodynamics: Fat in stool and stool weight. Lipase concentrations in stool: Amount of lipase excreted. | — |
Countries
Germany
Outcome results
None listed