AN OPEN-LABEL, SINGLE-DOSE, SINGLE-PERIOD STUDY DESIGNED TO ASSESS THE MASS BALANCE RECOVERY, METABOLITE PROFILE AND METABOLITE IDENTIFICATION OF [14C]-OLOROFIM ADMINISTERED VIA THE ORAL ROUTE TO HEALTHY MALE SUBJECTS.
Completed
- Conditions
- Serious fungal infections10017528
- Registration Number
- NL-OMON48360
- Lead Sponsor
- F2G Biotech GmBH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
healthy males
18 - 55 years
50 - 100 kilograms
BM) 18 - 30 kilograms/meter2
non smokers
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of
participation in another drug study within 90 days before the start of this
study or being a blood donor within 60 days from the start of the study. In
case of donating more than 1.5 liters of blood in the 10 months prior the start
of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method