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

NCT00856752 | Completed Phase 1

• 1 other identifier: NRL972-04A/2005 (IN-A)
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis

  Up to 6 hours post dose

Secondary Outcomes (1)

• Non-compartmental PK-analysis based on the extensive profile (up to last quantifiable data point), the 'short' profile (over the first hour after injection), and the two-point profile based on selected data-pairs over the 1st hour after dosing

  Up to 6 hours post dose

Study Arms (3)

T1

EXPERIMENTAL

Pre-treatment with rifampicin

Drug: NRL972

T2

EXPERIMENTAL

Pre-treatment with cyclosporin

Drug: NRL972

Reference

EXPERIMENTAL

Administration of NRL001 alone: no pre-treatment

Drug: NRL972

Interventions

NRL972 DRUG

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

T1

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
• Caucasian
• Age: 21 - 40 years
• BW 50 - 100 kg
• BMI 20 - 26 kg.m-2
• healthy based on the pre-study examination
• willing and able to provide informed consent

You may not qualify if:

• General - all subjects
• Previous participation in the trial
• Participant in any other trial during the last 90 days
• Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
• History of any clinically relevant allergy (including hypersensitivity to the trial medications)
• Presence of acute or chronic infection
• Presence or history of any relevant co-morbidity
• Resting systolic blood pressure \> 160 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
• Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
• Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
• Positive serology for HBsAg, anti HBc and anti HCV
• Positive HIV test
• Positive alcohol or urine drug test on recruitment (and upon admission)
• History of alcohol and/or drug abuse and/or daily use of \> 30 gr alcohol
• Smoking more than 15 cigarettes/day or equivalent of other tobacco products

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Dept. Clinical Pharmacology & Therapeutics, MHAPT "Zaritza Johanna" University Hospital

Sofia, 1527, Bulgaria

Location

MeSH Terms

Interventions

NRL972

Study Officials

• Hans J Gruss, MD

  Norgine Ltd

  STUDY DIRECTOR

• Emil Gatchev, PD Dr

  MHAPT "Zaritza Johanna" University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: June 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: August 1, 2006
• Last Updated: March 6, 2009

Record last verified: 2009-03

Locations

BU (1)