Healthy VolunteerPhase 1NCT05895266
A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers
A Phase 1 study testing ABBV-903 and Midazolam in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-903 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 2 Nov 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
- Negative test result for SARS-CoV-2 infection upon initial 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.
Who cannot join
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-Label Drug-Drug Interaction Study Between ABBV-903 and Midazolam
The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam in healthy adult participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-903, Midazolam
- Keywords
- Healthy Volunteer, ABBV-903, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-903Drug
Oral Tablet
MidazolamDrug
Oral Liquid
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Period 1 | Experimental | In Period 1 on Day 1, participants will receive liquid midazolam. Receives: Drug: Midazolam |
| Part 1: Period 2 | Experimental | In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 10, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days. Receives: Drug: ABBV-903; Drug: Midazolam |
| Part 2: Period 1 | Experimental | In Period 1 on Day 1, participants will receive liquid midazolam. Receives: Drug: Midazolam |
| Part 2: Period 2 | Experimental | In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 5, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days. Receives: Drug: ABBV-903; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
An 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.
Measured: Up to approximately 40 days
Maximum Plasma Concentration (Cmax) of ABBV-903
Cmax of ABBV-903
Measured: Up to approximately 40 days
Maximum Plasma Concentration (Cmax) of Midazolam
Cmax of midazolam
Measured: Up to approximately 40 days
Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam
Cmax of 1-OH-midazolam
Measured: Up to approximately 40 days
Time to Cmax (Tmax) of ABBV-903
Tmax of ABBV-903
Measured: Up to approximately 40 days
Time to Cmax (Tmax) of Midazolam
Tmax of midazolam
Measured: Up to approximately 40 days
Time to Cmax (Tmax) of 1-OH-Midazolam
Tmax of 1-OH-midazolam
Measured: Up to approximately 40 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-903
Terminal phase elimination half-life of ABBV-903
Measured: Up to approximately 40 days
Terminal Phase Elimination Half-Life (t1/2) of Midazolam
Terminal phase elimination half-life of midazolam
Measured: Up to approximately 40 days
Terminal Phase Elimination Half-Life (t1/2) of 1-OH-Midazolam
Terminal phase elimination half-life of 1-OH-midazolam
Measured: Up to approximately 40 days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903
AUCt of ABBV-903
Measured: Up to approximately 40 days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam
AUCt of midazolam
Measured: Up to approximately 40 days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of 1-OH-Midazolam
AUCt of 1-OH-midazolam
Measured: Up to approximately 40 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903
AUCinf of ABBV-903
Measured: Up to approximately 40 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam
AUCinf of midazolam
Measured: Up to approximately 40 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of 1-OH-Midazolam
AUCinf of 1-OH-midazolam
Measured: Up to approximately 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start23 Jun 2023
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT05895266
- Sponsor's protocol ID
- M24-225
- Status last verified
- Nov 2023
- First submitted
- 31 May 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desai JM, Chowdhury EA, Ali I, Lee CM, Schmidt JM, Orejudos A, Yadlapalli SL, Gupta S, Ocampo C, Miller MG, Salem AH, Mostafa NM. Pharmacokinetic Drug Interaction Studies of Limnetrelvir with Midazolam and Itraconazole in Healthy Participants. Clin Drug Investig. 2026 Jul;46(7):759-769. doi: 10.1007/s40261-026-01551-1. Epub 2026 Apr 16.
PubMed 42133202
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Drug-Drug Interaction Study Between ABBV-903 and Midazolam
- ClinicalTrials.gov ID
- NCT05895266
- Acronym / sponsor ID
- M24-225
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-903, Midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 8 Jun 2023 (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.
The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Period 1 | Experimental | Drug: MidazolamIn Period 1 on Day 1, participants will receive liquid midazolam. |
| Part 1: Period 2 | Experimental | Drug: ABBV-903, Drug: MidazolamIn Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 10, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days. |
| Part 2: Period 1 | Experimental | Drug: MidazolamIn Period 1 on Day 1, participants will receive liquid midazolam. |
| Part 2: Period 2 | Experimental | Drug: ABBV-903, Drug: MidazolamIn Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 5, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
- Negative test result for SARS-CoV-2 infection upon initial 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.
Key exclusion criteria (2 listed)
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.
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-903Oral Tablet | Drug | Part 1: Period 2, Part 2: Period 2 |
| MidazolamOral Liquid | Drug | Part 1: Period 1, Part 1: Period 2, Part 2: Period 1, Part 2: Period 2 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 40 days
An 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.
Maximum Plasma Concentration (Cmax) of ABBV-903
Time frame: Up to approximately 40 days
Cmax of ABBV-903
Maximum Plasma Concentration (Cmax) of Midazolam
Time frame: Up to approximately 40 days
Cmax of midazolam
Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam
Time frame: Up to approximately 40 days
Cmax of 1-OH-midazolam
Time to Cmax (Tmax) of ABBV-903
Time frame: Up to approximately 40 days
Tmax of ABBV-903
Time to Cmax (Tmax) of Midazolam
Time frame: Up to approximately 40 days
Tmax of midazolam
Time to Cmax (Tmax) of 1-OH-Midazolam
Time frame: Up to approximately 40 days
Tmax of 1-OH-midazolam
Terminal Phase Elimination Half-Life (t1/2) of ABBV-903
Time frame: Up to approximately 40 days
Terminal phase elimination half-life of ABBV-903
Terminal Phase Elimination Half-Life (t1/2) of Midazolam
Time frame: Up to approximately 40 days
Terminal phase elimination half-life of midazolam
Terminal Phase Elimination Half-Life (t1/2) of 1-OH-Midazolam
Time frame: Up to approximately 40 days
Terminal phase elimination half-life of 1-OH-midazolam
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903
Time frame: Up to approximately 40 days
AUCt of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam
Time frame: Up to approximately 40 days
AUCt of midazolam
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of 1-OH-Midazolam
Time frame: Up to approximately 40 days
AUCt of 1-OH-midazolam
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903
Time frame: Up to approximately 40 days
AUCinf of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam
Time frame: Up to approximately 40 days
AUCinf of midazolam
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of 1-OH-Midazolam
Time frame: Up to approximately 40 days
AUCinf of 1-OH-midazolam
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 9 Nov 2023.
- Derived from this study: PubMed 42133202Desai JM, Chowdhury EA, Ali I, Lee CM, Schmidt JM, Orejudos A, Yadlapalli SL, Gupta S, Ocampo C, Miller MG, Salem AH, Mostafa NM. Pharmacokinetic Drug Interaction Studies of Limnetrelvir with Midazolam and Itraconazole in Healthy Participants. Clin Drug Investig. 2026 Jul;46(7):759-769. doi: 10.1007/s40261-026-01551-1. Epub 2026 Apr 16.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 ABBV-903 and Midazolam 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 3 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: finished, as of the sponsor's last update on 9 Nov 2023. 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?
Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 40 days). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05895266, which also lists 1 linked publication.
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 9 Nov 2023.