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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45345

Enrollment

Registered

2017-03-07

Start date

2016-10-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal infection

Interventions

For Group 1a, the study will consist of 4 periods during which the volunteer will receive APX001 or placebo once per period. APX001 or placebo will be given as an intravenous infusion in the first p

Fungal infections

Eligibility

Age

18 Years to 64 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability: Evaluation of adverse events (AEs), physical examinations (PE), vital signs (VS), laboratory safety tests.	—

Secondary

Measure	Time frame
Pharmacokinetics, APX001 and/or APX001A, urinalysis and 12-lead electrocardiograms (ECG).	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)