Cirrhotic subjects with ascites and hyponatremia MedDRA version: 9.1 Level: LLT Classification code 10009213 Term: Cirrhosis of liver MedDRA version: 9.1 Level: LLT Classification code 10003445 Term: Ascites MedDRA version: 9.1 Level: LLT Classification code 10021038 Term: Hyponatremia
Conditions
Interventions
Product Name: M0002
Product Code: M0002
Pharmaceutical Form: Capsule*
Current Sponsor code: M0002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,3-
Pharmaceutica
Sponsors
Movetis NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female. Female subjects should be postmenopausal: prior oophorectomy, amenorrheic for 12 months or more in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression and follicle stimulating hormone and plasma estradiol in the postmenopausal range. 2. 18 – 75 years of age inclusive. 3. Subjects with any form of cirrhosis with ascites and who had at least 1 paracentesis of at least 4 liter in the last 6 months. 4. The diagnosis of cirrhosis must be confirmed by clinical findings such as evidence of portal hypertension (prominent abdominal wall veins, oesophageal varices, hypersplenism) and / or abnormal laboratory tests (LFTs, coagulation disorders (prolonged coagulation time), low platelet count, anaemia, low albumin, low total protein. The presence of ascites must be documented by ultrasound imaging. Duration since diagnosis should be noted. 5. Dose of diuretics of spironolactone and furosemide should be stable for at least one week prior to the screening visit or subject is refractory to diuretics. 6. Subjects must have been on a salt restricted diet (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women of child bearing potential (WOCBP). 2. Alcohol or drug abuse 4 weeks prior to screening and/or positive test at screening. 3. Malignancy. 4. Known renal impairment (serum creatinine > 2 mg/dL or 24-h creatinine clearance 120 beats per minute. 16. Any evidence of active myocardial ischemia, myocardial infarction in the last 6 months. 17. Subjects with clinically relevant abnormal ECG intervals of morphology of the ECG, QTc > 480 ms. 18. Positive HIV test. 19. Hemoglobin 5 x upper limit of normal, bilirubin > 10 mg/dL) 21. Serum potassium > 6.0 mmol/L or 295 mOs/kg. 22. Platelet count 2. 24. Participation in an investigational drug or device trial within 30 days prior to screening. 25. Use of the following therapeutic agents: salt tablets or hypertonic saline, NSAIDs, corticosteroids, anticoagulants, saline solution, vasopressin analogs, DDAVP, lithium, demeclocycline, oncologic agents, drugs with potent CYP 3A4 inhibitors (such as itraconazole, ketoconazole, erythromycin, ritonavir, indinavir, sequinavir, …) or drugs known to affect platelet function within 14 days prior to trial drug administration. 26. Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the subjects to comply with the trial requirements. 27. Any condition that in the opinion of the investigator(s) would complicate or compromise the trial or the well being of the subject or evidence of clinically relevant pathology that could interfere with the trial results or put the subject’s safety at risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of M0002 after multiple oral dosing compared with placebo. ;Secondary Objective: To assess the efficacy of M0002 after multiple oral dosing compared with placebo. To assess the pharmacokinetic behavior and relationship of the plasma drug concentration with the required effect of M0002 after multiple doses. ;Primary end point(s): To assess the safety and tolerability of M0002 after multiple oral dosing compared with placebo | — |
Countries
Belgium, Germany
Outcome results
None listed