Sensitivity of Alternative NRL972 Detection Methods in Healthy Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Norgine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT01164332
First received: July 13, 2010
Last updated: July 29, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Cirrhosis
Other: NRL972
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Investigation of the Sensitivity of Different Methods to Detect NRL972 in Healthy Volunteers During and After a 2-hour Intravenous Infusion of 10 and 30mg NRL972

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • Ratios of the plasma concentration at 30 minutes post-infusion to the concentrations at 10 and 15 minutes post-infusion [ Time Frame: Up to 4 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Up to 4 hours post-dose ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: Up to 4 hours post-dose ] [ Designated as safety issue: No ]
  • ECG [ Time Frame: Up to 4 hours post-dose ] [ Designated as safety issue: No ]
  • Clinical laboratory blood tests [ Time Frame: Up to 4 hours post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: August 2010
Estimated Study Completion Date: November 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Method A
First experimental detection method
Other: NRL972
Two-hour intravenous infusion of 5 and 15 mg per hour
Method B
Second experimental detection method
Other: NRL972
Two-hour intravenous infusion of 5 and 15 mg per hour

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
  • Smoking more than 10 cigarettes/day or equivalent of other tobacco products
  • Use of prohibited medication
  • Suspicion or evidence that the subject is not trustworthy and reliable
  • Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard

General - all females

  • Positive pregnancy test
  • Lactating
  • Not using appropriate contraception in premenopausal women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164332

Locations
Hungary
Phase I-II study clinical of the Drug Research Center Ltd.
Balatonfüred, Hungary, H-8230
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: Eva Peterfai, MD Drug Research Center Ltd
  More Information

No publications provided

Responsible Party: Vice President, Clinical Development, Norgine
ClinicalTrials.gov Identifier: NCT01164332     History of Changes
Other Study ID Numbers: NRL972-01/2010 (AMET)
Study First Received: July 13, 2010
Last Updated: July 29, 2011
Health Authority: Hungary: National Institute of Pharmacy

ClinicalTrials.gov processed this record on October 19, 2014