HealthyPhase 1NCT07610005
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
A Phase 1 study testing Varegacestat Reference Formulation, Varegacestat Test Formulation A and Varegacestat Test Formulation B in people with Healthy, run by Immunome, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Varegacestat Reference Formulation, Varegacestat Test Formulation A and Varegacestat Test Formulation B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Celerion, Inc.
Tempe, Arizona, 85283
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Varegacestat Reference Formulation, Varegacestat Test Formulation A, Varegacestat Test Formulation B, Varegacestat Test Formulation C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varegacestat Reference FormulationDrug
Oral administration
Varegacestat Test Formulation ADrug
Oral administration
Varegacestat Test Formulation BDrug
Oral administration
Varegacestat Test Formulation CDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Reference Formulation, then Test Formulation A | Experimental | Not described Receives: Drug: Varegacestat Reference Formulation; Drug: Varegacestat Test Formulation A |
| Part 1: Test Formulation A, then Reference Formulation | Experimental | Not described Receives: Drug: Varegacestat Reference Formulation; Drug: Varegacestat Test Formulation A |
| Part 2: Reference Formulation, then Test Formulation B | Experimental | Not described Receives: Drug: Varegacestat Reference Formulation; Drug: Varegacestat Test Formulation B |
| Part 2: Test Formulation B, then Reference Formulation | Experimental | Not described Receives: Drug: Varegacestat Reference Formulation; Drug: Varegacestat Test Formulation B |
| Part 2: Reference Formulation, then Test Formulation C | Experimental | Not described Receives: Drug: Varegacestat Reference Formulation; Drug: Varegacestat Test Formulation C |
| Part 2: Test Formulation C, then Reference Formulation | Experimental | Not described Receives: Drug: Varegacestat Reference Formulation; Drug: Varegacestat Test Formulation C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the rBA of varegacestat by AUC0-t
Measured: Approximately 3 weeks
Evaluate the rBA of varegacestat by AUC0-inf
Measured: Approximately 3 weeks
Evaluate the rBA of varegacestat by Cmax
Measured: Approximately 3 weeks
Secondary outcomes (4)
Assess the safety and tolerability of varegacestat by incidence of treatment emergent adverse events
Measured: Approximately 4 weeks
Assess the safety and tolerability of varegacestat by incidence of laboratory abnormalities
Measured: Approximately 3 weeks
Assess the safety and tolerability of varegacestat by incidence of changes in vital signs from baseline
Measured: Approximately 3 weeks
Assess the safety and tolerability of varegacestat by incidence of changes from baseline of 12-lead ECG assessments
Measured: Approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start21 May 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunome, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610005
- Sponsor's protocol ID
- VAR-505
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07610005
- Acronym / sponsor ID
- VAR-505
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Immunome, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Reference Formulation, then Test Formulation A | Experimental | Drug: Varegacestat Reference Formulation, Drug: Varegacestat Test Formulation A |
| Part 1: Test Formulation A, then Reference Formulation | Experimental | Drug: Varegacestat Reference Formulation, Drug: Varegacestat Test Formulation A |
| Part 2: Reference Formulation, then Test Formulation B | Experimental | Drug: Varegacestat Reference Formulation, Drug: Varegacestat Test Formulation B |
| Part 2: Test Formulation B, then Reference Formulation | Experimental | Drug: Varegacestat Reference Formulation, Drug: Varegacestat Test Formulation B |
| Part 2: Reference Formulation, then Test Formulation C | Experimental | Drug: Varegacestat Reference Formulation, Drug: Varegacestat Test Formulation C |
| Part 2: Test Formulation C, then Reference Formulation | Experimental | Drug: Varegacestat Reference Formulation, Drug: Varegacestat Test Formulation C |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varegacestat Reference FormulationOral administration | Drug | Part 1: Reference Formulation, then Test Formulation A, Part 1: Test Formulation A, then Reference Formulation, Part 2: Reference Formulation, then Test Formulation B, Part 2: Reference Formulation, then Test Formulation C, Part 2: Test Formulation B, then Reference Formulation, Part 2: Test Formulation C, then Reference Formulation |
| Varegacestat Test Formulation AOral administration | Drug | Part 1: Reference Formulation, then Test Formulation A, Part 1: Test Formulation A, then Reference Formulation |
| Varegacestat Test Formulation BOral administration | Drug | Part 2: Reference Formulation, then Test Formulation B, Part 2: Test Formulation B, then Reference Formulation |
| Varegacestat Test Formulation COral administration | Drug | Part 2: Reference Formulation, then Test Formulation C, Part 2: Test Formulation C, then Reference Formulation |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Varegacestat Reference Formulation, Varegacestat Test Formulation A and Varegacestat Test Formulation B in people with Healthy, run by Immunome, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Immunome Medical Monitor (425.939.7410, info@immunome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the rBA of varegacestat by AUC0-t (time frame: Approximately 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.