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

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00857480
First received: March 5, 2009
Last updated: March 6, 2009
Last verified: March 2009

March 5, 2009
March 6, 2009
June 2006
August 2006   (final data collection date for primary outcome measure)
Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis [ Time Frame: 4 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00857480 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 4 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of the PK of NRL972 Following Pre- and co-Administration of Ursodeoxycholic Acid and Cloxacillin
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 B: Interaction With Ursodeoxycholic Acid and Cloxacillin

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Hepatic Cirrhosis
  • Drug: NRL972
    Single intravenous administration of 2 mg NRL972
  • Drug: NRL972
    Pre-treatment and co-treatment with 1 g Cloxacillin t.i.d. for three days from the morning of D-3 until the morning of Day D01 0:30 hour before the intravenous administration of NRL972.
  • Drug: NRL972
    Three week pre-treatment with daily doses of 500 mg b.i.d ursodeoxycholic acid from the morning of D-20 until the evening of Day D-1
  • Experimental: Reference
    No pre-treatment
    Intervention: Drug: NRL972
  • Experimental: T1
    Cloxacillin pre- and co-treatment
    Intervention: Drug: NRL972
  • Experimental: T2
    UDCA pre-treatment
    Intervention: Drug: NRL972
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2006
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

General - all subjects

  1. Previous participation in the trial
  2. Participant in any other trial during the last 90 days
  3. Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
  4. History of any clinically relevant allergy (including hypersensitivity to the trial medications)
  5. Presence of acute or chronic infection
  6. Presence or history of any relevant co-morbidity
  7. Resting systolic blood pressure > 160 or < 90 mmHg, diastolic blood pressure > 95 or < 50 mmHg
  8. Clinically relevant ECG-abnormalities, prolonged QTc with > 450 msec in males and > 460 msec in females in particular
  9. Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
  10. Positive serology for HBsAg, anti HBc and anti HCV
  11. Positive HIV test
  12. Positive alcohol or urine drug test on recruitment (and upon admission)
  13. History of alcohol and/or drug abuse and/or daily use of > 30 gr alcohol
  14. Smoking more than 15 cigarettes/day or equivalent of other tobacco products
  15. Use of prohibited medication
  16. Suspicion or evidence that the subject is not trustworthy and reliable
  17. 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

  18. Positive pregnancy test
  19. Lactating
  20. Not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods [condom, diaphragm with spermicidal gel] should be us
Both
21 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Bulgaria
 
NCT00857480
NRL972-05/2005 (IN-B)
No
Vice President Clinical Development, Norgine Ltd
Norgine
Not Provided
Study Director: Hans-Jürgen Gruss, MD Norgine
Principal Investigator: Emil Gatchev, PD Dr med MHAPT "Zarita Johanna" University Hospital
Norgine
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP