A Randomised, Placebo-controlled, Double-blind, Cross-over Study in Healthy Men and Women to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intra-anal Doses of NRL001 for Three Doses Using a Cream Formulation Relative to a Matched Placebo Formulation for Reference
A Randomised, Placebo-controlled, Double-blind, Cross-over Study in Healthy Men and Women to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intra-anal Doses of NRL001 for Three Doses Using a Cream Formulation Relative to a Matched Placebo Formulation for Reference
This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.
Inclusion Criteria:
IN.1) sex: male and female (non-child-bearing potential or using medically adequate contraception
IN.2) race: Caucasian
IN.3) BW: 50 - 100 kg
IN.4) BMI: 20 - 28 kg.m-2
IN.5) age: 21 - 50 years
IN.6) type: healthy on the basis of specified criteria evaluated at the screening visit
IN.7) willing and able to provide informed consent
Exclusion Criteria:
General
EX.1) Previous participation in the trial
EX.2) Participant in any other trial during the last 90 days
EX.3) Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
EX.4) History of any clinically relevant allergy (including hypersensitivity to the trial medications)
EX.5) Presence of acute or chronic infection
EX.6) Presence or history of any relevant co-morbidity
EX.7) Resting systolic blood pressure > 140 or < 90 mmHg, diastolic blood pressure > 95 or < 50 mmHg
EX.8) Clinically relevant ECG-abnormalities, prolonged QTc with > 450 msec in males and > 460 msec in females in particular
EX.9) Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
EX.10) Positive serology for HBsAg, anti HBc and anti HCV
EX.11) Positive HIV test
EX.12) Positive alcohol or urine drug test on recruitment (and upon admission)
EX.13) History of alcohol and/or drug abuse and/or daily use of > 30 gr alcohol
EX.14) Smoking more than 15 cigarettes/day or equivalent of other tobacco products
EX.15) Use of prohibited medication
EX.16) Suspicion or evidence that the subject is not trustworthy and reliable
EX.17) 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
EX.18) Positive pregnancy test
EX.19) Lactating
EX.20) 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 used in addition).