A single center, open-label Phase 1 trial to evaluate the mass balance and metabolite profile of a single oral dose of pritelivir.
- Conditions
- Herpes simplex virus (HSV)Herpes
- Registration Number
- NL-OMON50254
- Lead Sponsor
- AiCuris Anti-infective Cures AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method