A Bioequivalence Study of APX001 High-load and Low-load Tablets

Basilea Pharmaceutica

Status and phase: Completed; Phase 1

Conditions: Invasive Fungal Infections

Treatments: Drug: APX001A; Drug: APX001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05491733

APX001-108

C4791008 (Other Identifier)

Details and patient eligibility

About

A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
• Minimum body weight of 50 kg.
• Screening hematology, clinical chemistry, coagulation, and urinalysis consistent with overall good health and having an estimated glomerular filtration rate (eGFR) >80 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula.

Exclusion criteria

• 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.
• History or presence of neurological disorders including abnormal movements or seizures.
• 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.
• Significant and/or acute illness or chronic infection, as judged by the investigator, including, but not limited to: upper airway infection, urinary tract infection, or skin infection within 30 days prior to the first study drug administration.
• Taking any drug or herbal CYP3A modulator (e.g., erythromycin; St. John's Wort) within 4 weeks (or 5 half-lives, whichever is longer) or any other nutrients known to modulate CYP3A activity (e.g., grapefruit juice; Seville orange) within 2 weeks prior to the first admission.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

APX001 Treatment A

Active Comparator group

Description:

Oral tablet with a 25% drug load (low-load) in fasted participants

Treatment:

Drug: APX001

Drug: APX001A

APX001A Treatment B

Experimental group

Description:

Oral tablet with a high drug load in fasted participants

Treatment:

Drug: APX001

Drug: APX001A

APX001A Treatment C

Experimental group

Description:

Oral tablet with a high drug load in participants that are not fasted.

Treatment:

Drug: APX001

Drug: APX001A