NCT00857480

Evaluation of the PK of NRL972 Following Pre- and co-Administration of Ursodeoxycholic Acid and Cloxacillin

A Single-Centre, Open, Controlled, Randomised Cross-Over Study in Healthy Male and Female Volunteers to Evaluate the Pharmacokinetics of Cholyl-Lysyl-Fluorescein (NRL972) in the Presence of Medication-Induced Changes in Cytochrome P450 or Biliary Transporter Proteins. Part B: Interaction With Ursodeoxycholic Acid and Cloxacillin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how NRL972 is processed within the body.

Conditions

• Hepatic Cirrhosis

Interventions

Type	Name	Description
DRUG	NRL972	Single intravenous administration of 2 mg NRL972
DRUG	NRL972	Pre-treatment and co-treatment with 1 g Cloxacillin t.i.d. for three days from the morning of D-3 until the morning of Day D01 0:30 hour before the intravenous administration of NRL972.
DRUG	NRL972	Three week pre-treatment with daily doses of 500 mg b.i.d ursodeoxycholic acid from the morning of D-20 until the evening of Day D-1

Timeline

• Start date: 2006-06-01
• Primary completion: 2006-08-01
• Completion: 2006-10-01
• First posted: 2009-03-06
• Last updated: 2009-03-09

Locations

1 site across 1 country: Bulgaria