NL-OMON45345
Completed
Not Applicable
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 - APX001 Safety, PK, Bioavailability, FE, DDI Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amplyx Pharmaceuticals, Inc.
- Enrollment
- 46
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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