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
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