A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants

Immunome, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Healthy

Treatments

Drug: Varegacestat Reference Formulation

Drug: Varegacestat Test Formulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT07610005

VAR-505

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.