NCT00856752

Evaluation of the Pharmacokinetics of NRL972 Following Pre-Administration of Rifampicin and Cyclosporine

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 A: Interaction With Rifampicin and Cyclosporine

• 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

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	NRL972	Single intravenous administration of 2 mg NRL972 after pre-treatment with 600 mg p.o. rifampicin once daily from the evening of Day D-7 until the evening of Day D-1
DRUG	NRL972	Reference test: Single intravenous administration of 2 mg NRL972
DRUG	NRL972	Single intravenous administration of 2 mg NRL972 injection after pre-treatment with 100 mg cyclosporine on the evening of Day D-1 and on the morning of Day D01 one hour before administration of NRL972

Timeline

• Start date: 2006-06-01
• Primary completion: 2006-07-01
• Completion: 2006-08-01
• First posted: 2009-03-06
• Last updated: 2009-03-06

Locations

1 site across 1 country: Bulgaria