None listed
Conditions
Brief summary
This is an open label study to measure the PK of oral OCX063, over 28 days of dosing in participants with chronic kidney disease (CKD). The study will be run in sequential cohorts, with the first 6 participants receiving a 50 mg dose of OCX063 per day and the following 6 participants receiving 100 mg OCX063 per day. An additional dose cohort of 25 mg or 75 mg may be added if PK data indicate that a lower dose may provide adequate exposure levels. Safety will also be assessed.
Interventions
Oral capsules of OCX063, to be taken in the morning on an empty stomach with water
- The first 6 participants will take 50 mg once daily for 28 days.
- The second 6 participants will take 100 mg once daily for 28 days
Depending on results from these 12 participants, an additional dose of either 25 mg or 75 mg may be studied. In that case 6 additional participants would take the selected dose once daily for 28 days.
Compliance will be monitored by review of a dosing diary and capsule count at ea
Oral capsules of OCX063, to be taken in the morning on an empty stomach with water - The first 6 participants will take 50 mg once daily for 28 days. - The second 6 participants will take 100 mg once daily for 28 days Depending on results from these 12 participants, an additional dose of either 25 mg or 75 mg may be studied. In that case 6 additional participants would take the selected dose once daily for 28 days. Compliance will be monitored by review of a dosing diary and capsule count at each visit
Sponsors
OccuRx Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
- Have an estimated glomerular filtration rate (eGFR) greater than or equal to 20 and less than or equal to 60 millilites per minute per body surface area. - Evidence of increased albuminuria for at least 3 months prior to Day 1 - Urinary albumin creatinine ratio greater than or equal to 30 mg/mmol, and/or urinary protein creatinine ratio greater than or equal to 50 milligrams per millimol - If requiring treatment with an angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), or sodium-glucose cotransporter-2 (SGLT2) inhibitor, must be on a stable dose for at least the 4 weeks prior to Day 1, with the intent to remain on that dose during the study period.
Exclusion criteria
- Have had a prior renal transplant, or likely to require renal transplant during the study period. - Have Autosomal Dominant Polycystic Kidney Disease (ADPKD) or documented inflammatory conditions, including lupus nephritis, and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) - Uncontrolled arterial hypertension defined as average of 3 systolic blood pressure readings of greater than or equal to 170 millimetre of mercury (mmHg) or an average of 3 diastolic blood pressure greater than or equal to 110 mmHg, - Peripheral vascular disease, chronic ulcers, or significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis. - Surgery within the 3 months prior to Day 1 or planned during the study period. - Chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function including, but not limited to, systemic corticosteroids exceeding 10 milligrams per day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of screening or planned during the study period. - Have aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH), or bilirubin values above the upper limit of normal (ULN) or evidence of hepatic disease as determined by history of hepatic encephalopathy, history of oesophageal varices, or history of portacaval shunt. - Haemoglobin less than 80 grams per litre, platelets less than 90 x 10^9 per litre, or neutrophil count less than 1.4 x 10^9 per litre.
Outcome results
None listed