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

Primary Purpose

Invasive Fungal Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

APX001

APX001A

About this trial

This is an interventional basic science trial for Invasive Fungal Infections focused on measuring fosmanogepix, candida, aspergillus, scedosporium, fusarium, mucorales, rhizopus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Pharmaceuticals Research Associates, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

APX001 Treatment A

APX001A Treatment B

APX001A Treatment C

Arm Description

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

Oral tablet with a high drug load in fasted participants

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

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

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

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

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

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

Plasma Decay Half-Life (t1/2)

Apparent Terminal Elimination Rate Constant (λz)

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

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

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

Number of Participants With Change From Baseline in Laboratory Tests Results

Number of Participants With Clinically Significant Change in Vital Signs

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

Number of Participants With Abnormalities in Physical Examinations

Secondary Outcome Measures

Full Information

NCT ID

NCT05491733

First Posted

August 4, 2022

Last Updated

August 4, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT05491733

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

March 2, 2021 (Actual)

Primary Completion Date

May 13, 2021 (Actual)

Study Completion Date

June 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Fungal Infections

Keywords

fosmanogepix, candida, aspergillus, scedosporium, fusarium, mucorales, rhizopus

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

APX001 Treatment A

Arm Type

Active Comparator

Arm Description

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

Arm Title

APX001A Treatment B

Arm Type

Experimental

Arm Description

Oral tablet with a high drug load in fasted participants

Arm Title

APX001A Treatment C

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

APX001

Other Intervention Name(s)

fosmanogepix

Intervention Description

Low-load oral tablet

Intervention Type

Drug

Intervention Name(s)

APX001A

Other Intervention Name(s)

fosmanogepix

Intervention Description

High-load oral tablet

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Time Frame