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Sensitivity of Alternative NRL972 Detection Methods in Healthy Subjects

Primary Purpose

Cirrhosis

Status

Completed

Phase

Phase 1

Locations

Hungary

Study Type

Interventional

Intervention

NRL972

About this trial

This is an interventional diagnostic trial for Cirrhosis

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Method A

Method B

Arm Description

First experimental detection method

Second experimental detection method

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events

Vital signs

ECG

Clinical laboratory blood tests

Full Information

NCT ID

NCT01164332

First Posted

July 13, 2010

Last Updated

June 9, 2015

Sponsor

Norgine

1. Study Identification

Unique Protocol Identification Number

NCT01164332

Brief Title

Sensitivity of Alternative NRL972 Detection Methods in Healthy Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norgine

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Cirrhosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Method A

Arm Type

Other

Arm Description

First experimental detection method

Arm Title

Method B

Arm Type

Other

Arm Description

Second experimental detection method

Intervention Type

Other

Intervention Name(s)

NRL972

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Adverse events

Time Frame

Up to 4 hours post-dose

Title

Vital signs

Time Frame

Up to 4 hours post-dose

Title

ECG

Time Frame

Up to 4 hours post-dose

Title

Clinical laboratory blood tests

Time Frame

Up to 4 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eva Peterfai, MD

Organizational Affiliation

Drug Research Center Ltd.

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Balatonfüred

ZIP/Postal Code

H-8230

Country

Hungary

12. IPD Sharing Statement

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Sensitivity of Alternative NRL972 Detection Methods in Healthy Subjects

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