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

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00856752
First received: March 5, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pharmacokinetics
Drug: NRL972
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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 A: Interaction With Rifampicin and Cyclosporine

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis [ Time Frame: Up to 6 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: Up to 6 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2006
Study Completion Date: August 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T1
Pre-treatment with rifampicin
Drug: NRL972
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
Experimental: T2
Pre-treatment with cyclosporin
Drug: NRL972
Single intravenous administration of 2 mg NRL972 injection after pre-treatment with 100 mg cyclosporine on the evening of Day D-1 and on the morning of Day D01 one hour before administration of NRL972
Experimental: Reference
Administration of NRL001 alone: no pre-treatment
Drug: NRL972
Reference test: Single intravenous administration of 2 mg NRL972

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 spermacide gel] should be used in addition).
  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: NCT00856752

Locations
Bulgaria
Dept. Clinical Pharmacology & Therapeutics, MHAPT "Zaritza Johanna" University Hospital
Sofia, Bulgaria, 1527
Sponsors and Collaborators
Norgine
Investigators
Study Director: Hans J Gruss, MD Norgine Ltd
Principal Investigator: Emil Gatchev, PD Dr MHAPT "Zaritza Johanna" University Hospital
  More Information

No publications provided

Responsible Party: Vice President Clinical Development, Norgine
ClinicalTrials.gov Identifier: NCT00856752     History of Changes
Other Study ID Numbers: NRL972-04A/2005 (IN-A)
Study First Received: March 5, 2009
Last Updated: March 5, 2009
Health Authority: Bulgaria: Ministry of Health

Additional relevant MeSH terms:
Rifampin
Cyclosporins
Cyclosporine
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2014