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CompletedNCT05491733Updated Jul 11, 2024

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

A Phase 1 interventional study of APX001 and APX001A in Invasive Fungal Infections, sponsored by Basilea Pharmaceutica. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-11.

Sponsored by Basilea Pharmaceutica · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was May 2021, 5 years 5 months ago, and no results have been posted to the registry.
  • Registered 1 year 5 months after the study started (first participant enrolled Mar 2021, registered Aug 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Invasive Fungal Infections

Keywords

  • fosmanogepix
  • candida
  • aspergillus
  • scedosporium
  • fusarium
  • mucorales
  • rhizopus
03

In context

Invasive Fungal Infections

152 studies on the registry are indexed under Invasive Fungal Infections; 35 are open to participants now.

This study's enrollment of 18 is below the median of 84 across 76 interventional studies indexed under Invasive Fungal Infections.

Browse Invasive Fungal Infections studies →

Lead sponsor

Basilea Pharmaceutica is the lead sponsor of 59 studies on the registry; 6 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.

Browse Basilea Pharmaceutica studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    APX001 Treatment A

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

    Drug: APX001 · Drug: APX001A

  • Experimental
    APX001A Treatment B

    Oral tablet with a high drug load in fasted participants

    Drug: APX001 · Drug: APX001A

  • Experimental
    APX001A Treatment C

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

    Drug: APX001 · Drug: APX001A

Interventions

  • DrugAPX001

    Low-load oral tablet

    Also known as: fosmanogepix

  • DrugAPX001A

    High-load oral tablet

    Also known as: fosmanogepix

06

What researchers measure

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

07

Study locations

1 site
  • Pharmaceuticals Research Associates, Inc
    Salt Lake City, Utah 84124, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in May 2021, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2022
First posted
Aug 8, 2022
StartActual
Mar 2, 2021
Primary completionActual
May 13, 2021
CompletionActual
Jun 23, 2021
Last update
Jul 11, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05491733
Lead sponsor
Basilea Pharmaceutica
Responsible party
Sponsor
First posted
Aug 8, 2022
Start date
Mar 2, 2021
Primary completion
May 13, 2021
Completion
Jun 23, 2021
Last update
Jul 11, 2024

Study contacts

Marc Engelhardt
study director · Basilea Pharmaceutica International Ltd, Allschwil

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Fosmanogepix

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