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 design

ordmark Arzneimittel GmbH0 sites20 target enrollmentOctober 31, 2006

Overview

No summary available.

Registry

who.int

Start Date

October 31, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

ordmark Arzneimittel GmbH

•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.

•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)).