Healthy VolunteerPhase 1NCT06579300
A Study to Assess Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088
A Phase 1 study testing ABBV-1088 and Itraconazole (ITZ) in people with Healthy Volunteer, run by AbbVie at 2 sites in United States.
Trial summary
This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants. This study will also assess drug-drug interaction between itraconazole and ABBV-1088 in healthy adult Western participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-1088 and Itraconazole (ITZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Sep 2024to 3 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) is > = 18.0 to < = 32.0 kg/m^2 after rounded to the tenths decimal, at Screening and upon confinement.
- 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.
- Part 3 Only: Han Chinese Participant must be first-or second-generation Han Chinese of full Chinese parentage. First-generation participants will have been born in China to two participants and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. OR
- Japanese Participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
Who cannot join
- Part 1 (Groups 1-4), Part 2 and Part 3: History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CenExel ACT- Anaheim Clinical Trials /ID# 276423
Anaheim, California, 92801
Acpru /Id# 270552
Grayslake, Illinois, 60030
About this study
Official title: A Phase 1 Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088
This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants. This study will also assess drug-drug interaction between itraconazole and ABBV-1088 in healthy adult Western participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-1088, Placebo for ABBV-1088, Itraconazole (ITZ)
- Keywords
- Healthy Volunteer, ABBV-1088, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-1088Drug
Oral Capsule
Placebo for ABBV-1088Drug
Oral Capsule
Itraconazole (ITZ)Drug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Group 1 ABBV-1088 Dose A | Experimental | Participants will receive ABBV-1088 dose A for 7 days Receives: Drug: ABBV-1088 |
| Part 1: Group 1 Placebo | Experimental | Participants will receive placebo for 7 days Receives: Drug: Placebo for ABBV-1088 |
| Part 1: Group 2 ABBV-1088 Dose B | Experimental | Participants will receive ABBV-1088 dose B for 21 days Receives: Drug: ABBV-1088 |
| Part 1: Group 2 Placebo | Experimental | Participants will receive placebo for 21 days Receives: Drug: Placebo for ABBV-1088 |
| Part 1: Group 3 ABBV-1088 Dose C | Experimental | Participants will receive ABBV-1088 dose C for 7 days Receives: Drug: ABBV-1088 |
| Part 1: Group 3 Placebo | Experimental | Participants will receive placebo for 7 days Receives: Drug: Placebo for ABBV-1088 |
| Part 1: Group 4 ABBV-1088 Dose D | Experimental | Participants will receive ABBV-1088 dose D for 21 days Receives: Drug: ABBV-1088 |
| Part 1: Group 4 Placebo | Experimental | Participants will receive placebo for 21 days Receives: Drug: Placebo for ABBV-1088 |
| Part 1: Group 5 ABBV-1088 Dose D | Experimental | Participants older than 60 years of age will receive ABBV-1088 dose D for 21 days Receives: Drug: ABBV-1088 |
| Part 1: Group 5 Placebo | Experimental | Participants older than 60 years of age will receive placebo for 21 days Receives: Drug: Placebo for ABBV-1088 |
| Part 2: Period 1 ABBV-1088 Dose A | Experimental | Participants will receive ABBV-1088 Dose A on day 1 Receives: Drug: ABBV-1088 |
| Part 2: Period 2 ABBV-1088 Dose A with ITZ | Experimental | Participants will receive ABBV-1088 dose A on day 4 with itraconazole (ITZ) for 10 days Receives: Drug: ABBV-1088; Drug: Itraconazole (ITZ) |
| Part 3: Group 1 ABBV-1088 Han Chinese Participants | Experimental | Han Chinese participants will receive ABBV-1088 dose E on day 1 Receives: Drug: ABBV-1088 |
| Part 3: Group 2 ABBV-1088 Japanese Participants | Experimental | Japanese participants will receive ABBV-1088 dose E on day 1 Receives: Drug: ABBV-1088 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088
Cmax of ABBV-1088
Measured: Up to approximately 24 days
Part 1, 2 and 3: Time to Cmax (Tmax) of ABBV-1088
Tmax of ABBV-1088
Measured: Up to approximately 24 days
Part 1, 2 and 3: Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088
Terminal phase elimination rate constant (beta) of ABBV-1088
Measured: Up to approximately 24 days
Part 1, 2 and 3: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
Terminal phase elimination half-life of ABBV-1088
Measured: Up to approximately 24 days
Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of ABBV-1088
AUCt of ABBV-1088
Measured: Up to approximately 24 days
Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of ABBV-1088
AUCinf of ABBV-1088
Measured: Up to approximately 24 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 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 54 days
Part 1: Trough Concentration (Ctrough) of ABBV-1088
Ctrough of of ABBV-1088
Measured: Up to approximately 24 days
Part 1: Area Under the Plasma Concentration-time Curve (AUC) for the First and Final Dose Intervals (AUCtau)
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).
Measured: Up to approximately 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start4 Sep 2024
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
Why it stopped: Strategic considerations
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 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
- NCT06579300
- Sponsor's protocol ID
- M24-931
- Status last verified
- Oct 2025
- First submitted
- 28 Aug 2024
- Last updated
- 30 Oct 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 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088
- ClinicalTrials.gov ID
- NCT06579300
- Acronym / sponsor ID
- M24-931
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-1088, Itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 30 Aug 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 will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants. This study will also assess drug-drug interaction between itraconazole and ABBV-1088 in healthy adult Western participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1: Group 1 ABBV-1088 Dose A | Experimental | Drug: ABBV-1088Participants will receive ABBV-1088 dose A for 7 days |
| Part 1: Group 1 Placebo | Experimental | Drug: Placebo for ABBV-1088Participants will receive placebo for 7 days |
| Part 1: Group 2 ABBV-1088 Dose B | Experimental | Drug: ABBV-1088Participants will receive ABBV-1088 dose B for 21 days |
| Part 1: Group 2 Placebo | Experimental | Drug: Placebo for ABBV-1088Participants will receive placebo for 21 days |
| Part 1: Group 3 ABBV-1088 Dose C | Experimental | Drug: ABBV-1088Participants will receive ABBV-1088 dose C for 7 days |
| Part 1: Group 3 Placebo | Experimental | Drug: Placebo for ABBV-1088Participants will receive placebo for 7 days |
| Part 1: Group 4 ABBV-1088 Dose D | Experimental | Drug: ABBV-1088Participants will receive ABBV-1088 dose D for 21 days |
| Part 1: Group 4 Placebo | Experimental | Drug: Placebo for ABBV-1088Participants will receive placebo for 21 days |
| Part 1: Group 5 ABBV-1088 Dose D | Experimental | Drug: ABBV-1088Participants older than 60 years of age will receive ABBV-1088 dose D for 21 days |
| Part 1: Group 5 Placebo | Experimental | Drug: Placebo for ABBV-1088Participants older than 60 years of age will receive placebo for 21 days |
| Part 2: Period 1 ABBV-1088 Dose A | Experimental | Drug: ABBV-1088Participants will receive ABBV-1088 Dose A on day 1 |
| Part 2: Period 2 ABBV-1088 Dose A with ITZ | Experimental | Drug: ABBV-1088, Drug: Itraconazole (ITZ)Participants will receive ABBV-1088 dose A on day 4 with itraconazole (ITZ) for 10 days |
| Part 3: Group 1 ABBV-1088 Han Chinese Participants | Experimental | Drug: ABBV-1088Han Chinese participants will receive ABBV-1088 dose E on day 1 |
| Part 3: Group 2 ABBV-1088 Japanese Participants | Experimental | Drug: ABBV-1088Japanese participants will receive ABBV-1088 dose E on day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) is > = 18.0 to < = 32.0 kg/m^2 after rounded to the tenths decimal, at Screening and upon confinement.
- 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.
- Part 3 Only: Han Chinese Participant must be first-or second-generation Han Chinese of full Chinese parentage. First-generation participants will have been born in China to two participants and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. OR
- Japanese Participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
Key exclusion criteria (2 listed)
- Part 1 (Groups 1-4), Part 2 and Part 3: History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years.
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 |
|---|---|---|
| ABBV-1088Oral Capsule | Drug | Part 1: Group 1 ABBV-1088 Dose A, Part 1: Group 2 ABBV-1088 Dose B, Part 1: Group 3 ABBV-1088 Dose C, Part 1: Group 4 ABBV-1088 Dose D, Part 1: Group 5 ABBV-1088 Dose D, Part 2: Period 1 ABBV-1088 Dose A, Part 2: Period 2 ABBV-1088 Dose A with ITZ, Part 3: Group 1 ABBV-1088 Han Chinese Participants, Part 3: Group 2 ABBV-1088 Japanese Participants |
| Placebo for ABBV-1088Oral Capsule | Drug | Part 1: Group 1 Placebo, Part 1: Group 2 Placebo, Part 1: Group 3 Placebo, Part 1: Group 4 Placebo, Part 1: Group 5 Placebo |
| Itraconazole (ITZ)Oral Capsule | Drug | Part 2: Period 2 ABBV-1088 Dose A with ITZ |
Primary outcome
Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088
Time frame: Up to approximately 24 days
Cmax of ABBV-1088
Part 1, 2 and 3: Time to Cmax (Tmax) of ABBV-1088
Time frame: Up to approximately 24 days
Tmax of ABBV-1088
Part 1, 2 and 3: Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088
Time frame: Up to approximately 24 days
Terminal phase elimination rate constant (beta) of ABBV-1088
Part 1, 2 and 3: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
Time frame: Up to approximately 24 days
Terminal phase elimination half-life of ABBV-1088
Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of ABBV-1088
Time frame: Up to approximately 24 days
AUCt of ABBV-1088
Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of ABBV-1088
Time frame: Up to approximately 24 days
AUCinf of ABBV-1088
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 54 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 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
Part 1: Trough Concentration (Ctrough) of ABBV-1088
Time frame: Up to approximately 24 days
Ctrough of of ABBV-1088
Part 1: Area Under the Plasma Concentration-time Curve (AUC) for the First and Final Dose Intervals (AUCtau)
Time frame: Up to approximately 24 days
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).
Results and safety
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No
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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.
ABBVIE INC. study director
AbbVie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-1088 and Itraconazole (ITZ) in people with Healthy Volunteer, run by AbbVie at 2 sites 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 4 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: stopped early, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Strategic considerations). Results are not available in the source record.
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?
Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088 (time frame: Up to approximately 24 days). The study lists 9 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 30 Oct 2025.