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Recruiting NCT07610005

A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Varegacestat Reference Formulation, Varegacestat Test Formulation.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Open-Label, Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Varegacestat Administered in Different Dose Forms in Healthy Participants

Overview

This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting conditions.

Interventions

  • Drug Varegacestat Reference Formulation
    Oral administration
  • Drug Varegacestat Test Formulation
    Oral administration

Primary outcome measures

  • Evaluate the rBA of varegacestat by AUC0-t [Time frame: Approximately 3 weeks]
  • Evaluate the rBA of varegacestat by AUC0-inf [Time frame: Approximately 3 weeks]
  • Evaluate the rBA of varegacestat by Cmax [Time frame: Approximately 3 weeks]
Secondary outcome measures (4)
  • Assess the safety and tolerability of varegacestat by incidence of treatment emergent adverse events [Time frame: Approximately 4 weeks]
  • Assess the safety and tolerability of varegacestat by incidence of laboratory abnormalities [Time frame: Approximately 3 weeks]
  • Assess the safety and tolerability of varegacestat by incidence of changes in vital signs from baseline [Time frame: Approximately 3 weeks]
  • Assess the safety and tolerability of varegacestat by incidence of changes from baseline of 12-lead ECG assessments [Time frame: Approximately 3 weeks]

Eligibility criteria

Inclusion criteria

  • Healthy, adult, female of non childbearing potential or male, 18 to 55 years of age, inclusive, at the screening visit
  • Male participants must follow protocol-specified contraception guidance
  • Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing
  • BMI ≥ 18.0 and ≤ 32.0 kg/m2 and with a body weight > 50 kg at the screening visit
  • Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee
  • Able to swallow multiple capsules

Exclusion criteria

  • Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee
  • History of any illness that, in the opinion of the PI or designee might confound the results of the study or poses an additional risk to the participant by their participation in the study
  • History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
  • History or presence of hypersensitivity or idiosyncratic reaction to varegacestat or related compounds
  • History or presence of:
  • Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus
  • Thrombophlebitis or deep vein thrombosis
  • Hematologic or coagulation disorders
  • Liver disease or dysfunction; Gilbert's syndrome
  • Renal dysfunction or glomerulonephritis
  • Cancer (except treated basal cell carcinoma of the skin and cancer-free for 5 years, non metastatic basal or squamous cell carcinoma of the skin, and cervical carcinoma in situ)
  • Clinically significant cardiovascular, gastrointestinal, pulmonary, endocrine, central nervous system disorders, or other major active and uncontrolled disease in the opinion of the PI or designee.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Celerion, Inc. — Tempe

Identifiers

NCT: NCT07610005 · VAR-505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗