Fungal infections Fungal infections
Conditions
Interventions
APX001 will be given as an intravenous infusion.
Cohort 1
Itraconazole will be administered after the subjects have fasted for at least
10 hours. At least 1 hour after administration of itraconazole
Sponsors
Amplyx Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects, aged 18 to 60 years inclusive at Screening. - Women must be postmenopausal or surgically sterile, or - Women of childbearing potential, with a fertile male sexual partner, must agree to avoid pregnancy during the study and to use 2 methods of birth control (using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom) at least 2 weeks before the start of study drug administration (as long as on one effective method for at least 3 cycles prior to dosing), or abstinence, which is considered an effective method if it is defined as a lifestyle preference (refraining from heterosexual intercourse) for the duration of study participation, and for 3 months after the last dose of study drug. At Screening and at Admission on Day -1, female subjects must be nonpregnant and nonlactating. - Male subjects with partner(s) of childbearing potential must agree to use appropriate barrier contraception to avoid fathering a child from first Admission to the clinical research unit until 3 months after receiving the last dose of study drug. They must commit to abstinence from heterosexual intercourse, or agree to use appropriate barrier contraception, and the use of hormonal contraceptives or an intrauterine device by the female partner. Male subjects must not donate sperm from first Admission to the clinical research unit until 3 months after receiving the last dose of study drug. 2. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive. 3. Weight : >=50 kg. 4. Screening hematology, clinical chemistry, coagulation, and urinalysis consistent with overall good health and the following criteria are met: - Creatinine within normal limits. - Estimated (Chronic Kidney Disease Epidemiology Collaboration equation) creatinine clearance within normal limits. 5. Able to understand and comply with the requirements of the study, willing to return for all clinic visits, including the confinement periods, and complete all study-related procedures. 6. Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Having any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential. 2. History or presence of malignancy within the past year. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled. 3. Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, or skin infection within 30 days preceding entry into the study. 4. Significant and/or acute illness within 5 days prior to the first study drug administration that may impact safety assessments, in the opinion of the Investigator. 5. Participation in an investigational drug study within 60 days prior to the first study drug administration in the current study. Participation in more than 3 other drug studies in the 10 months prior to the first study drug administration in the current study. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1 The effects of multiple doses of a CYP3A4 inhibitor, itraconazole (oral solution), on the PK of APX001 and APX001A, following IV administration of 500 mg APX001 (as a 3-hour infusion) bid for 1 day, with a dosing interval of approximately 9 hours. Cohort 2 The effects of multiple doses of a pan-CYP inducer, oral rifampin, on the PK of APX001 and APX001A, following IV administration of 1000 mg APX001 (as a 3-hour infusion) bid for 1 day, with a dosing interval of approximately 9 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1 Safety and tolerability of an IV dose (500 mg as a 3-hour infusion bid for 1 day, with a dosing interval of approximately 9 hours) of APX001 alone and when co-administered with itraconazole (oral solution). Cohort 2 Safety and tolerability of an IV dose (1000 mg as a 3-hour infusion bid for 1 day, with a dosing interval of approximately 9 hours) of APX001 alone and when co-administered with oral rifampin. | — |
Countries
Netherlands
Outcome results
None listed