A Phase I Clinical Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36

NCT01372124 | Completed Phase 1

• 1 other identifier: SNOXE36C201
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Renal Impairment

Keywords

Renal impairment; NOX-E36

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

Study Arms (1)

NOX-E36

EXPERIMENTAL

All subjects included in this study will receive the same dose of NOX E36.

Drug: NOX-E36

Interventions

NOX-E36 DRUG

All subjects included in this study will receive the same dose of NOX E36. In previous clinical trials, single intravenous doses of NOX E36 up to 2 mg/kg body weight and single subcutaneous doses of up to 0.5 mg/kg body weight appeared to be safe and well tolerated in healthy volunteers. Pharmacokinetic analyses have shown dose linearity

NOX-E36

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects (age 18-75 years, both inclusive)
• 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.
• 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
• Body Mass Index (BMI) between 22 and 40 kg/m², both inclusive.

You may not qualify if:

• Women of childbearing potential
• Patients who have received kidney transplantation.
• Patients receiving hemodialysis to control their disease.
• 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.
• Not able to communicate meaningfully with the investigator and staff.

Sponsors & Collaborators

• TME Pharma AG: lead

Study Sites (2)

DRC

Balatonfüred, 8230, Hungary

Location

Innophar Mo S.R.L.

Chisinau, Moldova

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Boris Sazu, MD

  INNOPHAR MO s.R.L.

  PRINCIPAL INVESTIGATOR

• Éva Péterfai

  DRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 13, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 19, 2012

Record last verified: 2012-10

Locations

MO (1); HU (1)