Status:
COMPLETED
Sensitivity of Alternative NRL972 Detection Methods in Healthy Subjects
Lead Sponsor:
Norgine
Conditions:
Cirrhosis
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
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 ap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01164332
Start Date
July 1 2010
End Date
November 1 2011
Last Update
June 10 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Phase I-II study clinical of the Drug Research Center Ltd.
Balatonfüred, Hungary, H-8230