A Phase I Clinical Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36
Information source: NOXXON Pharma AG
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Impairment
Intervention: NOX-E36 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: NOXXON Pharma AG Official(s) and/or principal investigator(s): Boris Sazu, MD, Principal Investigator, Affiliation: INNOPHAR MO s.R.L. Éva Péterfai, Principal Investigator, Affiliation: DRC
Summary
This is a multi center, open label, parallel group, single administration, phase I trial, in
subjects with mild, moderate or severe renal impairment and a control group with normal
renal function.
Clinical Details
Official title: A Phase I, Open Label, Parallel Group, Multi-center Single Dose Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetics
Detailed description:
Current diabetes therapy does not stop progression of the disease and the development of
diabetes mellitus (DM)-associated complications. A major concern in DM-patients is renal
impairment due to nephropathy leading to a reduced glomerular filtration rate (GFR). It has
been established that chronic (sub)clinical inflammation is crucial for the onset and
progression of DM.
CCL2, also known as Monocyte chemoattractant protein 1 (MCP 1) is a chemokine from the
cysteine-cysteine family, secreted by leukocytes or tissue cells. CCL2 promotes monocyte
emigration from the bone marrow, activates monocytes and macrophages and directs their
migration to sites of inflammation. Recent animal studies and clinical trials indicate a
critical involvement of CCL2 in DM and diabetic nephropathy, suggesting that CCL2 may be a
potential target for therapeutic intervention in DM. Finally, protein overload and oxidative
challenge of the diseased kidney was suggested to stimulate CCL2 expression in renal tubuli,
thereby accelerating the progression of diabetic nephropathy.
As NOX E36 is designed to specifically target human MCP-1/CCL2. This study is performed to
evaluate the role of renal impairment for adequate dosing recommendations in the planned
target population.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male and female subjects (age 18-75 years, both inclusive)
2. Male subjects who agree to sexual abstinence and/or use a highly effective method of
birth control. Female partners of male subjects must be of non-child bearing
potential or must practice an adequate non-hormonal contraceptive method to prevent
pregnancies.
3. Subjects will be categorized as follows based on creatinine clearance(mL/min/1. 73m2):
Normal renal function: CrCl > 80; mild renal impairment: 50 ≤ CrCl ≤ 80; moderate
renal impairment: 30 ≤ CrCl ≤ 50; severe renal impairment: CrCl < 30
4. Body Mass Index (BMI) between 22 and 40 kg/m², both inclusive.
Exclusion Criteria:
1. Women of childbearing potential
2. Patients who have received kidney transplantation.
3. Patients receiving hemodialysis to control their disease.
4. Any clinically significant abnormality other than related to the renal impairment
following the investigator's review of the physical examination, ECG and clinical
laboratory tests at screening.
5. Not able to communicate meaningfully with the investigator and staff.
Locations and Contacts
DRC, Balatonfüred 8230, Hungary
Innophar Mo S.R.L., Chisinau, Moldova, Republic of
Additional Information
Starting date: June 2011
Last updated: October 18, 2012
|