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

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 spermacide gel] should be used in addition).