Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
12 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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