Healthy VolunteersPhase 1NCT07599761
A Phase 1 Study to Assess the Effect of Itraconazole on ABBV-722 in Healthy Adult Participants
A Phase 1 study testing ABBV-722 and Itraconazole in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
The objective of this study is to assess the effect of repeated doses of itraconazole on the single dose pharmacokinetics (PK) of ABBV-722. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ABBV-722 and Itraconazole
- 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
- 7 May 2026to 3 Sep 2026
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laboratory values meet the criteria specified in the protocol.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
Who cannot join
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
- Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study treatment administration.
- Use of tobacco- or nicotine-containing products within 3 months (90 days) prior to the first dose of study treatment.
- Participant has prior exposure to ABBV-722 within 90 days prior to the first dose of study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics, Safety, and Tolerability of ABBV-722 in Healthy Adult Subjects
The objective of this study is to assess the effect of repeated doses of itraconazole on the single dose pharmacokinetics (PK) of ABBV-722.
- Conditions
- Healthy Volunteers
- Being tested
- ABBV-722, Itraconazole
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-722Drug
Oral Tablet
ItraconazoleDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Period 1 & 2 | Experimental | In Period 1, participants will receive a single dose of ABBV-722. In Period 2, participants will receive multiple daily doses of Itraconazole and a single dose of ABBV-722. Receives: Drug: ABBV-722; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of ABBV-722
Cmax of ABBV-722
Measured: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Time to Cmax (Tmax) of ABBV-722
Tmax of ABBV-722
Measured: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-722
AUCt of ABBV-722
Measured: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722
AUCinf of ABBV-722
Measured: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Terminal Phase Elimination Rate Constant (β) of ABBV-722
β of ABBV-722
Measured: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722
t1/2 of ABBV-722
Measured: Up to Day 8 in Period 1 and Up to Day 14 in Period 2
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately 45 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start7 May 2026
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- NCT07599761
- Sponsor's protocol ID
- M25-294
- Status last verified
- Sep 2026
- First submitted
- 7 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No