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Official title A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
ClinicalTrials.gov ID: NCT07610005
What this study is testing
What is Varegacestat Reference Formulation?
Varegacestat Reference Formulation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the...
- 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...
- 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:
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tempe, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tempe, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.