Healthy VolunteerPhase 1NCT06855264
A Cardiac Liability Study of Varegacestat in Healthy Participants
A Phase 1 study testing varegacestat and Moxifloxacin 400 mg in people with Healthy Volunteer, run by Immunome, Inc. at 1 site in United States.
Trial summary
This clinical study is designed to study the effect of a single dose of varegacestat on cardiac repolarization in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- varegacestat and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 6 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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, male or female (of non childbearing potential), 18 to 55 years of age, inclusive, at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, and vital signs, as deemed by the PI or designee
Who cannot join
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
- Have taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Single-Dose, Positive- and Placebo-Controlled, 3-Way Crossover Study to Evaluate the Effects of Varegacestat on Cardiac Repolarization in Healthy Participants
This clinical study is designed to study the effect of a single dose of varegacestat on cardiac repolarization in healthy adult participants.
Read the detailed description
This is a double-blind (with respect to varegacestat and placebo only), single-dose, randomized, placebo- and positive- controlled, 3-way crossover study.
On Day 1 of each period, participants will receive one of 3 treatments: a single dose of varegacestat (Treatment A), a single dose of varegacestat matching placebo (Treatment B), or a single dose of moxifloxacin (Treatment C). In each period, cardiodynamic ECGs will be collected predose and for 24 hours postdose. PK samples will be collected predose and up to 168 hours post-dose for assessments of varegacestat and AL102 MTB, and up to 24 hours post-dose for assessment of moxifloxacin.
There will be a washout of at least 14 days between doses. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
- Conditions
- Healthy Volunteer
- Being tested
- varegacestat, Placebo, Moxifloxacin 400 mg
- Keywords
- thorough-QT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varegacestatDrug
Single oral dose of varegacestat
PlaceboDrug
Single oral dose of placebo
Moxifloxacin 400 mgDrug
Single oral dose of moxifloxacin
| Study group | Role | What they receive |
|---|---|---|
| Varegacestat | Experimental | Not described Receives: Drug: varegacestat |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | Not described Receives: Drug: Moxifloxacin 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected change from baseline QTc and varegacestat and its metabolite, AL102 MTB, plasma concentrations
Measured: 24 hours
Secondary outcomes (8)
Change from baseline, placebo-corrected, and categorical outliers of the ECG parameter HR from a single oral dose of varegacestat.
Measured: 24 hours
Change from baseline and placebo-corrected ECG parameter QT from a single oral dose of varegacestat.
Measured: 24 hours
Change from baseline, placebo-corrected, and categorical outliers of the ECG parameter QTcF from a single oral dose of varegacestat.
Measured: 24 hours
The AUC from time 0 extrapolated to infinity, calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant of varegacesatat and AL102-MTB (varegacestat metabolite).
Measured: 7 days
Maximum observed concentration (Cmax) of varegacesatat and AL102-MTB (varegacestat metabolite).
Measured: 7 days
Apparent first-order terminal elimination half-life (t1/2) will be calculated as 0.693/Kel of varegacesatat and AL102-MTB (varegacestat metabolite).
Measured: 7 days
Safety and tolerability of a single oral dose of varegacestat by incidences of treatment-emergent adverse events.
Measured: Approximately 56 days
Assay sensitivity of the study to detect a small QTc effect using moxifloxacin as a positive control.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start24 Feb 2025
- Primary completion8 Apr 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunome, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855264
- Sponsor's protocol ID
- AL102-502
- Status last verified
- Sep 2025
- First submitted
- 25 Feb 2025
- Last updated
- 24 Sep 2025
- 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single-Dose, Positive- and Placebo-Controlled, 3-Way Crossover Study to Evaluate the Effects of Varegacestat on Cardiac Repolarization in Healthy Participants
- ClinicalTrials.gov ID
- NCT06855264
- Acronym / sponsor ID
- AL102-502
- Conditions
- Healthy Volunteer
- Keywords
- thorough-QT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Immunome, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 3 Mar 2025 (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 clinical study is designed to study the effect of a single dose of varegacestat on cardiac repolarization in healthy adult participants.
Detailed description
This is a double-blind (with respect to varegacestat and placebo only), single-dose, randomized, placebo- and positive- controlled, 3-way crossover study.
On Day 1 of each period, participants will receive one of 3 treatments: a single dose of varegacestat (Treatment A), a single dose of varegacestat matching placebo (Treatment B), or a single dose of moxifloxacin (Treatment C). In each period, cardiodynamic ECGs will be collected predose and for 24 hours postdose. PK samples will be collected predose and up to 168 hours post-dose for assessments of varegacestat and AL102 MTB, and up to 24 hours post-dose for assessment of moxifloxacin.
There will be a washout of at least 14 days between doses. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Varegacestat | Experimental | Drug: varegacestat |
| Placebo | Placebo comparator | Drug: Placebo |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin 400 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy, adult, male or female (of non childbearing potential), 18 to 55 years of age, inclusive, at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, and vital signs, as deemed by the PI or designee
Key exclusion criteria (2 listed)
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
- Have taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer.
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 |
|---|---|---|
| varegacestatSingle oral dose of varegacestat | Drug | Varegacestat |
| PlaceboSingle oral dose of placebo | Drug | Placebo |
| Moxifloxacin 400 mgSingle oral dose of moxifloxacin | Drug | Moxifloxacin |
Primary outcome
Placebo-corrected change from baseline QTc and varegacestat and its metabolite, AL102 MTB, plasma concentrations
Time frame: 24 hours
8 secondary outcomes
Change from baseline, placebo-corrected, and categorical outliers of the ECG parameter HR from a single oral dose of varegacestat.
Time frame: 24 hours
Change from baseline and placebo-corrected ECG parameter QT from a single oral dose of varegacestat.
Time frame: 24 hours
Change from baseline, placebo-corrected, and categorical outliers of the ECG parameter QTcF from a single oral dose of varegacestat.
Time frame: 24 hours
The AUC from time 0 extrapolated to infinity, calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant of varegacesatat and AL102-MTB (varegacestat metabolite).
Time frame: 7 days
Maximum observed concentration (Cmax) of varegacesatat and AL102-MTB (varegacestat metabolite).
Time frame: 7 days
Apparent first-order terminal elimination half-life (t1/2) will be calculated as 0.693/Kel of varegacesatat and AL102-MTB (varegacestat metabolite).
Time frame: 7 days
Safety and tolerability of a single oral dose of varegacestat by incidences of treatment-emergent adverse events.
Time frame: Approximately 56 days
Assay sensitivity of the study to detect a small QTc effect using moxifloxacin as a positive control.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Moxifloxacin 400 mg in people with Healthy Volunteer, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 24 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo-corrected change from baseline QTc and varegacestat and its metabolite, AL102 MTB, plasma concentrations (time frame: 24 hours). 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 24 Sep 2025.