Sensitivity of Alternative NRL972 Detection Methods in Healthy Subjects

NCT01164332 | Completed Phase 1

• 1 other identifier: NRL972-01/2010 (AMET)
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The disposition of NRL972 after a 15-second intravenous injection of 2 mg NRL972 is distinctly slower in patients with hepatic cirrhosis and acute hepatitis than in healthy control subjects. NRL972 appears to be a suitable investigational marker of hepatic transporter clearance dysfunction. Although the pharmacokinetics of NRL972 provide a reliable differentiation between subject groups, this approach relies on precisely timed sampling of venous blood, cautious preparation, handling and on-site storage of plasma samples, the transfer of samples to a central laboratory for analysis, and the availability of a validated assay procedure. For these reasons, there is interest in developing and validating alternative methods for determining the concentration of NRL972 in venous blood. Two such methods have been developed to date, but their utility in determining NRL972 pharmacokinetics has yet to be established.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Ratios of the plasma concentration at 30 minutes post-infusion to the concentrations at 10 and 15 minutes post-infusion

  Up to 4 hours post-dose

Secondary Outcomes (4)

• Adverse events

  Up to 4 hours post-dose

• Vital signs

  Up to 4 hours post-dose

• ECG

  Up to 4 hours post-dose

• Clinical laboratory blood tests

  Up to 4 hours post-dose

Study Arms (2)

Method A

OTHER

First experimental detection method

Other: NRL972

Method B

OTHER

Second experimental detection method

Other: NRL972

Interventions

NRL972 OTHER

Two-hour intravenous infusion of 5 and 15 mg per hour

Method A; Method B

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects meeting the following conditions will be eligible for enrolment:
• Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
• Caucasian
• Age: 20 to 45 years
• BMI 20 - 26 kg.m-2
• Healthy based on the pre-study examination
• Suitable veins for easy cannulation
• Willing and able to provide informed consent

You may not qualify if:

• Subjects of any of the following categories will be excluded from enrolment:
• 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
• Presence of any 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
• History of alcohol and/or drug abuse and/or daily use of \> 30 g alcohol

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Phase I-II study clinical of the Drug Research Center Ltd.

Balatonfüred, H-8230, Hungary

Location

MeSH Terms

Conditions

Fibrosis

Interventions

NRL972

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva Peterfai, MD

  Drug Research Center Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2011
• Last Updated: June 10, 2015

Record last verified: 2011-07

Locations

HU (1)