Healthy VolunteerPhase 1NCT06677996
A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants
A Phase 1 study testing varegacestat and Itraconazole (200 mg) in people with Healthy Volunteer, run by Immunome, Inc. at 1 site in United States.
Trial summary
This is an open label, fixed sequence, 1-way crossover drug-drug interaction (DDI) study in healthy 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 Itraconazole (200 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 7 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 only), 18 to 55 years of age, inclusive, 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Fixed Sequence, 1-way Crossover Study Examining the Effect of Itraconazole on the Pharmacokinetics, Safety and Tolerability After Varegacestat Single Dose Administration to Healthy Participants
This is an open label, fixed sequence, 1-way crossover drug-drug interaction (DDI) study in healthy participants.
Read the detailed description
This is a phase 1, open-label, fixed sequence, 1-way crossover study examining the effect of itraconazole on the pharmacokinetics, safety and tolerability after varegacestat single dose administration to healthy participants. This is a 2-period study. In period 1 a single dose of varegacestat will be administered with PK evaluated predose and up to 192 hours postdose. There will be a 14 -day washout between period 1 and period 2. In period 2, itraconzole will be administered once daily for 18 consecutive days. Beginning on Day 4 of Period 2 a single dose of varegacestat will be administered 30 minutes after itraconazole dosing. Blood samples for PK will be collected prior to varegacestat dosing and up to 744 hours post varegacestat dosing for varegacestat and its metabolite.
- Conditions
- Healthy Volunteer
- Being tested
- varegacestat, Itraconazole (200 mg)
- Keywords
- Drug-Drug Interaction, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varegacestatDrug
Experimental intervention
Itraconazole (200 mg)Drug
Intervention to evaluate DDI with experimental intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Period 1: varegacestat administration for PK followed by Period 2: itraconazole and varegacestat administration for PK and DDI Receives: Drug: varegacestat; Drug: Itraconazole (200 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of itraconazole on the PK of varegacestat in healthy participants.
AUC0-t for varegacestat administered with and without itraconazole.
Measured: Up to 5 weeks
Effect of itraconazole on the PK of varegacestat in healthy participants.
AUC0-inf for varegacestat administered with and without itraconazole.
Measured: Up to 5 weeks
Effect of itraconazole on the PK of varegacestat in healthy participants.
Cmax for varegacestat administered with and without itraconazole.
Measured: Up to 5 weeks
Effect of itraconazole on the PK of varegacestat in healthy participants.
Tmax for varegacestat administered with and without itraconazole.
Measured: Up to 5 weeks
Secondary outcomes (4)
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.
Number of subjects who experience treatment-emergent adverse events (TEAEs)
Measured: Up to 2 months
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.
Number of subjects who experience abnormalities in clinical laboratory tests such as serum chemistry and hematology
Measured: Up to 2 months
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.
Number of subjects who experience 12-lead ECG abnormalities
Measured: Up to 2 months
Ctrough of itraconazole and hydroxy-itraconazole in combination with varegacestat in healthy participants.
Ctrough. values on prior to dosing itraconazole
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start11 Nov 2024
- Primary completion30 Dec 2024
- Study completion7 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunome, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Valentine, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677996
- Sponsor's protocol ID
- AL102-501
- Status last verified
- May 2025
- First submitted
- 4 Nov 2024
- Last updated
- 11 May 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 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed Sequence, 1-way Crossover Study Examining the Effect of Itraconazole on the Pharmacokinetics, Safety and Tolerability After Varegacestat Single Dose Administration to Healthy Participants
- ClinicalTrials.gov ID
- NCT06677996
- Acronym / sponsor ID
- AL102-501
- Conditions
- Healthy Volunteer
- Keywords
- Drug-Drug Interaction, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Immunome, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 7 Nov 2024 (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, fixed sequence, 1-way crossover drug-drug interaction (DDI) study in healthy participants.
Detailed description
This is a phase 1, open-label, fixed sequence, 1-way crossover study examining the effect of itraconazole on the pharmacokinetics, safety and tolerability after varegacestat single dose administration to healthy participants. This is a 2-period study. In period 1 a single dose of varegacestat will be administered with PK evaluated predose and up to 192 hours postdose. There will be a 14 -day washout between period 1 and period 2. In period 2, itraconzole will be administered once daily for 18 consecutive days. Beginning on Day 4 of Period 2 a single dose of varegacestat will be administered 30 minutes after itraconazole dosing. Blood samples for PK will be collected prior to varegacestat dosing and up to 744 hours post varegacestat dosing for varegacestat and its metabolite.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: varegacestat, Drug: Itraconazole (200 mg)Period 1: varegacestat administration for PK followed by Period 2: itraconazole and varegacestat administration for PK and DDI |
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 only), 18 to 55 years of age, inclusive, 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 (3 listed)
- 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.
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 |
|---|---|---|
| varegacestatExperimental intervention | Drug | Treatment Arm |
| Itraconazole (200 mg)Intervention to evaluate DDI with experimental intervention | Drug | Treatment Arm |
Primary outcome
Effect of itraconazole on the PK of varegacestat in healthy participants.
Time frame: Up to 5 weeks
AUC0-t for varegacestat administered with and without itraconazole.
Effect of itraconazole on the PK of varegacestat in healthy participants.
Time frame: Up to 5 weeks
AUC0-inf for varegacestat administered with and without itraconazole.
Effect of itraconazole on the PK of varegacestat in healthy participants.
Time frame: Up to 5 weeks
Cmax for varegacestat administered with and without itraconazole.
Effect of itraconazole on the PK of varegacestat in healthy participants.
Time frame: Up to 5 weeks
Tmax for varegacestat administered with and without itraconazole.
4 secondary outcomes
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.
Time frame: Up to 2 months
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.
Time frame: Up to 2 months
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.
Time frame: Up to 2 months
Ctrough of itraconazole and hydroxy-itraconazole in combination with varegacestat in healthy participants.
Time frame: Up to 5 weeks
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 11 May 2025.
- 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. This study is not recruiting at the moment.
Michelle Valentine principal investigator
Celerion
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 Itraconazole (200 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 3 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 11 May 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. 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?
Effect of itraconazole on the PK of varegacestat in healthy participants. (time frame: Up to 5 weeks). The study lists 4 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 11 May 2025.