Healthy VolunteerPhase 1NCT05691699
A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults
A Phase 1 study testing ABBV-903 and Itraconazole in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers. 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 Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 23 Oct 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
- Body Mass Index (BMI) is => 18.0 to <= 32 kg/m2 after rounded to the nearest tenth, at Screening and 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 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 drug.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 First in Human, Single and Multiple Ascending Dose and Food Effect and Drug-Drug Interaction in Healthy Subjects to Evaluate the Safety, Tolerability and Assessment of Pharmacokinetics of ABBV-903
The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-903, Placebo for ABBV-903, Itraconazole
- Keywords
- ABBV-903
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-903Drug
Capsule; oral
Placebo for ABBV-903Drug
Capsule; oral
ItraconazoleDrug
Capsule; oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1, ABBV-903 | Experimental | Participants will receive a single ascending dose of ABBV-903 in Part 1. Receives: Drug: ABBV-903 |
| Part 1, Placebo | Experimental | Participants will receive a single ascending dose of placebo in Part 1. Receives: Drug: Placebo for ABBV-903 |
| Part 2, ABBV-903 | Experimental | Participants will receive multiple ascending doses of ABBV-903 in Part 2. Receives: Drug: ABBV-903 |
| Part 2, Placebo | Experimental | Participants will receive multiple ascending doses of placebo in Part 2. Receives: Drug: Placebo for ABBV-903 |
| Part 3, Sequence 1 | Experimental | Participants in Part 3 will follow Sequence 1. Receives: Drug: ABBV-903; Drug: Itraconazole |
| Part 3, Sequence 2 | Experimental | Participants in Part 3 will follow Sequence 2. Receives: Drug: ABBV-903; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Cmax will be assessed.
Measured: Baseline to Day 36
Time to Cmax (Tmax)
Tmax will be assessed.
Measured: Baseline to Day 36
Apparent Terminal Phase Elimination Constant (β)
Apparent terminal phase elimination constant (β) will be assessed.
Measured: Baseline to Day 36
Terminal Phase Elimination Half-life (t1/2)
Terminal phase elimination half-life (t1/2) will be assessed.
Measured: Baseline to Day 36
Area Under the Plasma Concentration-time Curve (AUC)
AUC will be assessed.
Measured: Baseline to Day 36
Area Under the Plasma Concentration-time Curve from Time 0 Until the Last Measurable Concentration (AUCt)
AUCt will be assessed.
Measured: Baseline to Day 36
Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf)
AUCinf will be assessed.
Measured: Baseline to Day 36
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: Baseline to Day 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start3 Jan 2023
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 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
- NCT05691699
- Sponsor's protocol ID
- M24-112
- Status last verified
- Oct 2023
- First submitted
- 9 Jan 2023
- Last updated
- 30 Oct 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 42133202Chowdhury EA, Lee CM, Desai JM, Ali I, Orejudos A, Gupta SV, Ocampo CJ, Miller MG, Jayanth J, Schmidt JM, Salem AH, Mostafa NM. Pharmacokinetic profiling of limnetrelvir in non-Japanese and Japanese populations: results of two phase 1 single- and multiple-dose studies. Antimicrob Agents Chemother. 2026 May 6;70(5):e0144325. doi: 10.1128/aac.01443-25. Epub 2026 Mar 23.
PubMed 41870065
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First in Human, Single and Multiple Ascending Dose and Food Effect and Drug-Drug Interaction in Healthy Subjects to Evaluate the Safety, Tolerability and Assessment of Pharmacokinetics of ABBV-903
- ClinicalTrials.gov ID
- NCT05691699
- Acronym / sponsor ID
- M24-112
- Conditions
- Healthy Volunteer
- Keywords
- ABBV-903
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 20 Jan 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 purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1, ABBV-903 | Experimental | Drug: ABBV-903Participants will receive a single ascending dose of ABBV-903 in Part 1. |
| Part 1, Placebo | Experimental | Drug: Placebo for ABBV-903Participants will receive a single ascending dose of placebo in Part 1. |
| Part 2, ABBV-903 | Experimental | Drug: ABBV-903Participants will receive multiple ascending doses of ABBV-903 in Part 2. |
| Part 2, Placebo | Experimental | Drug: Placebo for ABBV-903Participants will receive multiple ascending doses of placebo in Part 2. |
| Part 3, Sequence 1 | Experimental | Drug: ABBV-903, Drug: ItraconazoleParticipants in Part 3 will follow Sequence 1. |
| Part 3, Sequence 2 | Experimental | Drug: ABBV-903, Drug: ItraconazoleParticipants in Part 3 will follow Sequence 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) is => 18.0 to <= 32 kg/m2 after rounded to the nearest tenth, at Screening and 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 electrocardiogram (ECG).
Key exclusion criteria (3 listed)
- 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 drug.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
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-903Capsule; oral | Drug | Part 1, ABBV-903, Part 2, ABBV-903, Part 3, Sequence 1, Part 3, Sequence 2 |
| Placebo for ABBV-903Capsule; oral | Drug | Part 1, Placebo, Part 2, Placebo |
| ItraconazoleCapsule; oral | Drug | Part 3, Sequence 1, Part 3, Sequence 2 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Baseline to Day 36
Cmax will be assessed.
Time to Cmax (Tmax)
Time frame: Baseline to Day 36
Tmax will be assessed.
Apparent Terminal Phase Elimination Constant (β)
Time frame: Baseline to Day 36
Apparent terminal phase elimination constant (β) will be assessed.
Terminal Phase Elimination Half-life (t1/2)
Time frame: Baseline to Day 36
Terminal phase elimination half-life (t1/2) will be assessed.
Area Under the Plasma Concentration-time Curve (AUC)
Time frame: Baseline to Day 36
AUC will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 Until the Last Measurable Concentration (AUCt)
Time frame: Baseline to Day 36
AUCt will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf)
Time frame: Baseline to Day 36
AUCinf will be assessed.
Number of Participants with Adverse Events (AEs)
Time frame: Baseline to Day 66
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.
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 30 Oct 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.
- Derived from this study: PubMed 41870065Chowdhury EA, Lee CM, Desai JM, Ali I, Orejudos A, Gupta SV, Ocampo CJ, Miller MG, Jayanth J, Schmidt JM, Salem AH, Mostafa NM. Pharmacokinetic profiling of limnetrelvir in non-Japanese and Japanese populations: results of two phase 1 single- and multiple-dose studies. Antimicrob Agents Chemother. 2026 May 6;70(5):e0144325. doi: 10.1128/aac.01443-25. Epub 2026 Mar 23.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
RecruitingObservational study
Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
Healthy Volunteer
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
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 Itraconazole 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 30 Oct 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?
Maximum Observed Plasma Concentration (Cmax) (time frame: Baseline to Day 36). 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?
On the ClinicalTrials.gov record for NCT05691699, which also lists 2 linked publications.
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 2023; AzTrials last refreshed its copy on 3 Nov 2026.