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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Renal Impairment
Interventions
DRUG

NOX-E36

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

Trial Locations (2)

8230

DRC, Balatonfüred

Unknown

Innophar Mo S.R.L., Chisinau

All Listed Sponsors
lead

TME Pharma AG

INDUSTRY

NCT01372124 - A Phase I Clinical Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36 | Biotech Hunter | Biotech Hunter