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The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Period 1 | Experimental | In Period 1 on Day 1, participants will receive liquid midazolam. |
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| 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. |
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| Part 2: Period 1 | Experimental | In Period 1 on Day 1, participants will receive liquid midazolam. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-903 | Drug | Oral Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 40 days |
| Maximum Plasma Concentration (Cmax) of ABBV-903 | Cmax of ABBV-903 | Up to approximately 40 days |
| Maximum Plasma Concentration (Cmax) of Midazolam | Cmax of midazolam | Up to approximately 40 days |
| Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam | Cmax of 1-OH-midazolam | Up to approximately 40 days |
| Time to Cmax (Tmax) of ABBV-903 | Tmax of ABBV-903 | Up to approximately 40 days |
| Time to Cmax (Tmax) of Midazolam | Tmax of midazolam | Up to approximately 40 days |
| Time to Cmax (Tmax) of 1-OH-Midazolam | Tmax of 1-OH-midazolam | Up to approximately 40 days |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-903 | Terminal phase elimination half-life of ABBV-903 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 254970 | Grayslake | Illinois | 60030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42133202 | Derived | 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 Apr 16. doi: 10.1007/s40261-026-01551-1. Online ahead of print. |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam |
| Drug |
Oral Liquid |
|
| Up to approximately 40 days |
| Terminal Phase Elimination Half-Life (t1/2) of Midazolam | Terminal phase elimination half-life of midazolam | 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 | 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 | Up to approximately 40 days |
| Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam | AUCt of midazolam | 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 | Up to approximately 40 days |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903 | AUCinf of ABBV-903 | Up to approximately 40 days |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam | AUCinf of midazolam | 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 | Up to approximately 40 days |
| D006571 | Heterocyclic Compounds |