Healthy VolunteerPhase 1529 DDI ITZNCT06722430
A Study to Assess Change in How Oral Icalcaprant With Itraconazole Moves Through the Body in Healthy Adult Participants
A Phase 1 study testing Icalcaprant and Itraconazole (ITZ) in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant 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?
- Icalcaprant and Itraconazole (ITZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to 13 Jan 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
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Who cannot join
- History of any clinically significant sensitivity or allergy to any medication or food.
- Exposure to icalcaprant within the past 90 days.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Icalcaprant in Healthy Adult Subjects
This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants.
- Conditions
- Healthy Volunteer
- Being tested
- Icalcaprant, Itraconazole (ITZ)
- Keywords
- Healthy Volunteer, Icalcaprant, Itraconazole, ABBV-1354, CVL-354
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcalcaprantDrug
Also called ABBV-1354, CVL-354
Oral capsule
Itraconazole (ITZ)Drug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Icalcaprant with Itraconazole | Experimental | Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days. Receives: Drug: Icalcaprant; Drug: Itraconazole (ITZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Icalcaprant
Cmax of Icalcaprant
Measured: Up to approximately 14 days
Time to Cmax (Tmax) of Icalcaprant
Tmax of Icalcaprant
Measured: Up to approximately 14 days
Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant
Beta of Icalcaprant
Measured: Up to approximately 14 days
Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant
T1/2 of Icalcaprant
Measured: Up to approximately 14 days
Area under the plasma concentration-time curve (AUC) of Icalcaprant
AUC of Icalcaprant
Measured: Up to approximately 14 days
Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant
AUCt of Icalcaprant
Measured: Up to approximately 14 days
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant
AUCinf of Icalcaprant
Measured: Up to approximately 14 days
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study
Measured: Up to approximately 47 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start13 Nov 2024
- Primary completion13 Jan 2025
- Study completion13 Jan 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.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722430
- Sponsor's protocol ID
- M25-529
- Acronym
- 529 DDI ITZ
- Status last verified
- Jan 2025
- First submitted
- 4 Dec 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Icalcaprant in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06722430
- Acronym / sponsor ID
- 529 DDI ITZ / M25-529
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, Icalcaprant, Itraconazole, ABBV-1354, CVL-354
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 9 Dec 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 study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icalcaprant with Itraconazole | Experimental | Drug: Icalcaprant, Drug: Itraconazole (ITZ)Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Key exclusion criteria (3 listed)
- History of any clinically significant sensitivity or allergy to any medication or food.
- Exposure to icalcaprant within the past 90 days.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
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 |
|---|---|---|
| IcalcaprantAlso: ABBV-1354, CVL-354Oral capsule | Drug | Icalcaprant with Itraconazole |
| Itraconazole (ITZ)Oral capsule | Drug | Icalcaprant with Itraconazole |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Icalcaprant
Time frame: Up to approximately 14 days
Cmax of Icalcaprant
Time to Cmax (Tmax) of Icalcaprant
Time frame: Up to approximately 14 days
Tmax of Icalcaprant
Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant
Time frame: Up to approximately 14 days
Beta of Icalcaprant
Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant
Time frame: Up to approximately 14 days
T1/2 of Icalcaprant
Area under the plasma concentration-time curve (AUC) of Icalcaprant
Time frame: Up to approximately 14 days
AUC of Icalcaprant
Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant
Time frame: Up to approximately 14 days
AUCt of Icalcaprant
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant
Time frame: Up to approximately 14 days
AUCinf of Icalcaprant
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 47 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study
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 28 Jan 2025.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
ABBVIE INC. study director
AbbVie
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 Icalcaprant and Itraconazole (ITZ) in people with Healthy Volunteer, run by AbbVie 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 28 Jan 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?
Maximum Observed Plasma Concentration (Cmax) of Icalcaprant (time frame: Up to approximately 14 days). The study lists 8 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 28 Jan 2025.