Herpes Simplex Virus HSV
Conditions
Interventions
The volunteer will be given pritelivir and celiprolol as tablets, flurbiprofen
and midazolam as a small drink, and bupropion as capsules via the mouth. The
volunteer will also be given 240 millilite
Sponsors
AiCuris Anti-infective Cures AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, and the potential risks and the discomfort to which he/she may be exposed and has given written consent to participation in the trial prior to trial start and any trial related procedure. - Healthy male and female subjects of any ethnic origin, aged between 18 and 55 years (inclusive). Assessed as healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, body temperature, ECG assessment, and clinical laboratory results. - In women negative serum β-HCG (beta-human chorionic gonadotropin) test at screening and negative urine β-HCG test on Day -1. - Subject agrees to pharmacogenetic blood sampling. - Normal body weight as evidenced by a Body Mass Index (BMI) >=18.0 and =50.0 kg at Screening. More criteria apply
Exclusion criteria
Exclusion criteria: 1. History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food. 2. History of allergic reactions to any active or inactive ingredient(s) of the Investigational Medicinal Products (IMPs). 3. History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease suspected to influence pharmacokinetics or safety of the IMPs. 4. History of malignancy within 5 years, unless one of the following, treated and considered cured: basal cell carcinoma, in situ cervical cancer, or breast ductal carcinoma in situ. 5. Resting pulse rate after 5 minutes in supine position at Screening and Day -1: 100 beats per minute (bpm), if out of range, up to one repeat assessment is allowed. More criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * AUC0-*, AUC0-last, Cmax of celiprolol, flurbiprofen, bupropion and midazolam • Hydroxy-bupropion to bupropion AUC0-* and AUC0-last ratios and hydroxy-flurbiprofen to flurbiprofen AUC0-* and AUC0-last ratios | — |
Secondary
| Measure | Time frame |
|---|---|
| • tmax, tlag, t1/2, CL/F, Vd/F, MRT of celiprolol, flurbiprofen, bupropion and midazolam in plasma • AUC0-*, AUC0-last, Cmax, , tmax, tlag, t1/2 of hydroxy-flurbiprofen and hydroxy-bupropion • Trough concentrations (C0h) of pritelivir and its metabolites AIC090015 and AIC090105 in plasma • AUC0-24h, Cmax,ss, Cmin, tmax, tlag, CL/F, Vd,ss/F, MRT of pritelivir in plasma • AUC0-24h, Cmax,ss, Cmin, tmax, tlag, CL/F, Vd,ss/F, MRT of pritelivir in blood • AUC0-24h, Cmax,ss, Cmin, tmax, tlag, MRT of metabolites AIC090015 and AIC090105 in plasma • AUC0-24h, Cmax,ss, Cmin, tmax, tlag, MRT of metabolites AIC090015 and AIC090105 in blood • The ratio between each of the metabolites AIC090015 and AIC090105 versus pritelivir • The blood/plasma ratio for pritelivir, AIC090015 and AIC090105 • The blood/plasma ratio for AUC0-*, AUC0-last, Cmax of pritelivir, AIC090015 and AIC090105 | — |
Countries
Netherlands
Outcome results
None listed