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Completed

NCT Number: NCT05491733

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

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.

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Key information

Conditions

Invasive Fungal Infections Bacterial Infections and Mycoses Infections Mycoses Torulopsis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaceuticals Research Associates, Inc

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APX001

Drug

Low-load oral tablet

Other names: fosmanogepix

APX001A

Drug

High-load oral tablet

Other names: fosmanogepix

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose

  4. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

    Time frame: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose

  5. Area Under the Curve From Time Zero to 24 hours (AUC0-24)

    Time frame: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose

  6. Percentage of Area Under the Curve Extrapolated to Infinity (%AUCextra)

    Time frame: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose

  7. Plasma Decay Half-Life (t1/2)

    Time frame: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose

  8. Apparent Terminal Elimination Rate Constant (λz)

    Time frame: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose

  9. Apparent Total clearance, Calculated as Dose/AUCinf (CL/F)

    Time frame: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose

  10. Apparent Volume of Distribution at Terminal Phase (Vz/F)

    Time frame: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose

  11. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Time frame: Baseline through Day 14

  12. Number of Participants With Change From Baseline in Laboratory Tests Results

    Time frame: Baseline through Day 14

  13. Number of Participants With Clinically Significant Change in Vital Signs

    Time frame: Baseline through Day 14

  14. Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities

    Time frame: Baseline through Day 14

  15. Number of Participants With Abnormalities in Physical Examinations

    Time frame: Baseline through Day 14

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 8, 2022
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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