Status:
COMPLETED
Evaluation of the Pharmacokinetics of NRL972 Following Pre-Administration of Rifampicin and Cyclosporine
Lead Sponsor:
Norgine
Conditions:
Pharmacokinetics
Eligibility:
All Genders
21-40 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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 \[condom, diaphragm with spermacide gel\] should be used in addition).
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00856752
Start Date
June 1 2006
End Date
August 1 2006
Last Update
March 6 2009
Active Locations (1)
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1
Dept. Clinical Pharmacology & Therapeutics, MHAPT "Zaritza Johanna" University Hospital
Sofia, Bulgaria, 1527