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 infection; 10017528

• Registration Number: NL-OMON45345
• Lead Sponsor: Amplyx Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

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>