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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-02

Study Completion Date

2021-06-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Human Bioequivalence Study of Amphotericin B Liposome for Injection

NCT06977490

Invasive Fungal Infections Neutropenic Fever Visceral Leishmaniasis

COMPLETED NA

Human Bioequivalence Study of Liposomal Amphotericin B for Injection

NCT06983665

Invasive Fungal Infections Neutropenic Fever Visceral Leishmaniasis

ACTIVE_NOT_RECRUITING NA

Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions

NCT00602498

Infection

COMPLETED NA

Bioequivalence Study of Apixaban Tablets in Healthy Chinese Subjects

NCT05841446

Healthy

COMPLETED PHASE1

Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants

NCT02230046

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Invasive Fungal Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

APX001 Treatment A

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

Group Type ACTIVE_COMPARATOR

APX001

Intervention Type DRUG

Low-load oral tablet

APX001A

Intervention Type DRUG

High-load oral tablet

APX001A Treatment B

Oral tablet with a high drug load in fasted participants

Group Type EXPERIMENTAL

APX001

Intervention Type DRUG

Low-load oral tablet

APX001A

Intervention Type DRUG

High-load oral tablet

APX001A Treatment C

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

Group Type EXPERIMENTAL

APX001

Intervention Type DRUG

Low-load oral tablet

APX001A

Intervention Type DRUG

High-load oral tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

APX001

Low-load oral tablet

Intervention Type DRUG

APX001A

High-load oral tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

fosmanogepix fosmanogepix

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes