A Relative Bioavailability and Bioequivalence Study of Va... | NCT07610005

NCT07610005

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reference Formulation, then Test Formulation	Experimental		Drug: Varegacestat Reference Formulation Drug: Varegacestat Test Formulation
Test Formulation, then Reference Formulation	Experimental		Drug: Varegacestat Reference Formulation Drug: Varegacestat Test Formulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Varegacestat Reference Formulation	Drug	Oral administration	Reference Formulation, then Test Formulation Test Formulation, then Reference Formulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the rBA of varegacestat by AUC0-t		Approximately 3 weeks
Evaluate the rBA of varegacestat by AUC0-inf		Approximately 3 weeks
Evaluate the rBA of varegacestat by Cmax		Approximately 3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Assess the safety and tolerability of varegacestat by incidence of treatment emergent adverse events		Approximately 4 weeks
Assess the safety and tolerability of varegacestat by incidence of laboratory abnormalities		Approximately 3 weeks

Eligibility Module

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.