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

Invasive Fungal Infections Clinical Trial

Official title:

A 3-Treatment, 3-Period, 6-Sequence Randomized Crossover Single-Dose Study Evaluating the Bioequivalence of High-Load and Low-Load Oral Tablet Formulations of Apx001 and the Effect of Food on the Absorption of Apx001 From the High-Load Tablet In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05491733
• Other study ID #: APX001-108
• Secondary ID: C4791008
• Status: Completed
• Phase: Phase 1
• Start date: March 2, 2021
• Est. completion date: June 23, 2021

Study information

• Verified date: May 2024
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 23, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• APX001
Low-load oral tablet
• APX001A
High-load oral tablet

Locations

Country	Name	City	State
United States	Pharmaceuticals Research Associates, Inc	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]		Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Primary	Area Under the Curve From Time Zero to 24 hours (AUC0-24)		Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Primary	Percentage of Area Under the Curve Extrapolated to Infinity (%AUCextra)		Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Primary	Plasma Decay Half-Life (t1/2)		Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Primary	Apparent Terminal Elimination Rate Constant (?z)		Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Primary	Apparent Total clearance, Calculated as Dose/AUCinf (CL/F)		Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Primary	Apparent Volume of Distribution at Terminal Phase (Vz/F)		Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Primary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)		Baseline through Day 14
Primary	Number of Participants With Change From Baseline in Laboratory Tests Results		Baseline through Day 14
Primary	Number of Participants With Clinically Significant Change in Vital Signs		Baseline through Day 14
Primary	Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities		Baseline through Day 14
Primary	Number of Participants With Abnormalities in Physical Examinations		Baseline through Day 14