A Phase 1, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses Oral Doses of APX001, to Investigate the Effect of Food on APX001 and to Investigate the Drug-Drug Interaction Potential of APX001
Completed
- Conditions
- Fungal infection10017528
- Registration Number
- NL-OMON45345
- Lead Sponsor
- Amplyx Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
Healthy male or female subjects
Age 18 to 55 years, inclusive
Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
Exclusion Criteria
Suffering from cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric diseases, or neoplastic disorder with metastatic potential. Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Pregnancy. Suffering from hepatitis B, hepatitis C, HIV/AIDS.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tolerability: Evaluation of adverse events (AEs), physical<br /><br>examinations (PE), vital signs (VS), laboratory safety tests.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetics, APX001 and/or APX001A, urinalysis and 12-lead<br /><br>electrocardiograms (ECG).</p><br>