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

Primary Purpose

Hepatic Cirrhosis

Status

Completed

Phase

Phase 1

Locations

Bulgaria

Study Type

Interventional

Intervention

NRL972

About this trial

This is an interventional diagnostic trial for Hepatic Cirrhosis

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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 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

Sites / Locations

MHAPT "Zarita Johanna" University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Reference

Arm Description

No pre-treatment

Cloxacillin pre- and co-treatment

UDCA pre-treatment

Outcomes

Primary Outcome Measures

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

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

Full Information

NCT ID

NCT00857480

First Posted

March 5, 2009

Last Updated

March 6, 2009

Sponsor

Norgine

1. Study Identification

Unique Protocol Identification Number

NCT00857480

Brief Title

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

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 B: Interaction With Ursodeoxycholic Acid and Cloxacillin

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Norgine

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Cirrhosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reference

Arm Type

Experimental

Arm Description

No pre-treatment

Arm Title

Arm Type

Experimental

Arm Description

Cloxacillin pre- and co-treatment

Arm Title

Arm Type

Experimental

Arm Description

UDCA pre-treatment

Intervention Type

Drug

Intervention Name(s)

NRL972

Intervention Description

Single intravenous administration of 2 mg NRL972

Intervention Type

Drug

Intervention Name(s)

NRL972

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

NRL972

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

4 hours post-dose

Secondary Outcome Measure Information:

Title

Time Frame

4 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans-Jürgen Gruss, MD

Organizational Affiliation

Norgine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Emil Gatchev, PD Dr med

Organizational Affiliation

MHAPT "Zarita Johanna" University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

MHAPT "Zarita Johanna" University Hospital

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

12. IPD Sharing Statement

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

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