NL-OMON47992
Completed
Not Applicable
A phase 1, open-label, fixed-sequence, drug-drug interaction study of APX001 to evaluate the effects of CYP3A4 inhibition and pan-CYP induction in two parallel groups of healthy male and female subjects - A DDI study of CYP3A4 inhibition and pan-CYP induction on APX001
ConditionsFungal infections
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fungal infections
- Sponsor
- Amplyx Pharmaceuticals, Inc.
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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