A phase 1 study to evaluate the absorption, metabolism and excretion of BCX7353 following administration of a single, oral dose of [14C]-radiolabeled BCX7353 to healthy male subjects.
Completed
- Conditions
- Generische aandoening.extremitiesgastrointestinal tract and upper airways.genitalsSwelling of face
- Registration Number
- NL-OMON44289
- Lead Sponsor
- BioCryst Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
Inclusion Criteria
healthy male subjects
18 - 65 years
BMI 18.0 - 32.0 kilograms/meter2
non smoking
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 <p>To determine the mass balance of [14C]-BCX7353.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine the radioprofile and identify metabolites of [14C]-BCX7353 in<br /><br>plasma, urine and feces following a single oral dose of [14C]-BCX7353<br /><br>To assess the pharmacokinetics (PK) of BCX7353 in plasma and urine following<br /><br>administration of an oral dose of [14C]-BCX7353<br /><br>To assess the PK of total radioactivity in plasma<br /><br>To assess the exposure of notable radiolabeled components using *AUC pooling*<br /><br>To provide additional safety and tolerability information for BCX7353</p><br>