Herpes simplex virus (HSV) Herpes
Conditions
Interventions
Not applicable.
Sponsors
AiCuris Anti-infective Cures AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated potential risks and the discomfort to which he may be exposed and has given written consent to participation in the trial prior to trial start and any trial-related procedure. 2. Male subjects of any ethnic origin aged between 18 and 55 years (inclusive). Assessed as otherwise healthy based on pre-trial examinations including medical history, physical examination, blood pressure, pulse rate, body temperature, ECG assessment, and clinical laboratory results. 3. Subjects not planning to father or to donate sperms for in vitro fertilization during three months after dosing of trial medication. Adequate contraception must be used during sexual intercourse with women of childbearing potential to make sure the fathering of a child will be ruled out during the trial and during the three months after dosing of trial medication. Adequate contraception is defined as a combination of a highly effective method of birth control and additional barrier contraception. Highly effective method of birth control is defined as follows: combined (estrogen and progesterone) oral contraceptives, combined hormonal vaginal rings, hormone implants, hormone injectables, or intrauterine device that need to be in place for a period of at least 2 months prior to screening. Additional barrier contraception (the following methods are allowed: condom of the male, diaphragm with spermicide, portio cap with spermicide) must be used for the duration of the trial, defined as from the time of screening to the end of trial examination, and for at least three full months after dosing of trial medication.
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 pritelivir or the capsule material (hydroxypropyl methyl cellulose [HPMC]). 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 pritelivir. 4. History of malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the mass balance of pritelivir, to profile and identify pritelivir metabolites in plasma and excreta (urine, feces) and to identify the routes of elimination of pritelivir in humans. To evaluate pharmacokinetics of pritelivir, AIC090015, AIC090105 and total radioactivity in plasma and blood and AIC090015 acyl glucuronide (AIC255698) in plasma only. To evaluate the blood/plasma ratios for total radioactivity, pritelivir, AIC090015 and AIC090105. To obtain additional information on the safety and tolerability of pritelivir. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed