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

NCT00857480 | Completed Phase 1

• 1 other identifier: NRL972-05/2005 (IN-B)
• 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

Hepatic Cirrhosis

Outcome Measures

Primary Outcomes (1)

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

  4 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

  4 hours post-dose

Study Arms (3)

Reference

EXPERIMENTAL

No pre-treatment

Drug: NRL972

T1

EXPERIMENTAL

Cloxacillin pre- and co-treatment

Drug: NRL972

T2

EXPERIMENTAL

UDCA pre-treatment

Drug: NRL972

Interventions

NRL972 DRUG

Single intravenous administration of 2 mg NRL972

Reference

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)

MHAPT "Zarita Johanna" University Hospital

Sofia, 1431, Bulgaria

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

NRL972

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans-Jürgen Gruss, MD

  Norgine

  STUDY DIRECTOR

• Emil Gatchev, PD Dr med

  MHAPT "Zarita 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: August 1, 2006
• Study Completion: October 1, 2006
• Last Updated: March 9, 2009

Record last verified: 2009-03

Locations

BU (1)