NL-OMON50254
Completed
Not Applicable
A single center, open-label Phase 1 trial to evaluate the mass balance and metabolite profile of a single oral dose of pritelivir. - Mass balance and metabolite profile of pritelivir.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Herpes simplex virus (HSV)
- Sponsor
- AiCuris Anti-infective Cures AG
- Enrollment
- 6
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Study to assess the safety of treatment of articular cartilage lesions with CartiLife®.Diseases of the musculo-skeletal system and connective tissueKCT0000560MCTT6
Completed
Phase 1
A study to investigate the processing by the body, safety, and side effects of gantenerumab in healthy Chinese participants following a single dosePharmacokinetics, safety, and tolerability of gantenerumabNot ApplicableISRCTN41969875Genentech, Inc.20
Not yet recruiting
Phase 1
A single-centre, open-label, phase I study to evaluate the diagnostic performance of 89Zirconium-labelled girentuximab (89Zr-TLX250) Position Emission Tomography (PET) in Urothelial Cancer PatientsMetastatic urothelial carcinomaBladder cancerCancer - BladderACTRN12621000411842South Metropolitan Health Services20
Recruiting
Phase 1
A pilot single center, open label trial to assess the impact of doxycycline postexposure prophylaxis on antimicrobial resistance (SafeDoxyPEP trial)Bacterial sexually transmittable diseases (chlamydia, gonorrhea, syphilis)Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]CTIS2023-507137-24-00Institute Of Tropical Medicine78
Recruiting
Not Applicable
Prospective trials to evaluate the safety of Allogeneic bone marrow derived mesenchymal stem cell in patients with Chronic Kidney DiseaseDiseases of the genitourinary systemKCT0006783Asan Medical Center10