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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, ABBV-903 | Experimental | Participants will receive a single ascending dose of ABBV-903 in Part 1. |
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| Part 1, Placebo | Experimental | Participants will receive a single ascending dose of placebo in Part 1. |
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| Part 2, ABBV-903 | Experimental | Participants will receive multiple ascending doses of ABBV-903 in Part 2. |
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| Part 2, Placebo | Experimental | Participants will receive multiple ascending doses of placebo in Part 2. |
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| Part 3, Sequence 1 | Experimental | Participants in Part 3 will follow Sequence 1. |
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| Part 3, Sequence 2 | Experimental | Participants in Part 3 will follow Sequence 2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-903 | Drug | Capsule; oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax will be assessed. | Baseline to Day 36 |
| Time to Cmax (Tmax) | Tmax will be assessed. | Baseline to Day 36 |
| Apparent Terminal Phase Elimination Constant (β) | Apparent terminal phase elimination constant (β) will be assessed. | Baseline to Day 36 |
| Terminal Phase Elimination Half-life (t1/2) | Terminal phase elimination half-life (t1/2) will be assessed. | Baseline to Day 36 |
| Area Under the Plasma Concentration-time Curve (AUC) | AUC will be assessed. | Baseline to Day 36 |
| Area Under the Plasma Concentration-time Curve from Time 0 Until the Last Measurable Concentration (AUCt) | AUCt will be assessed. | Baseline to Day 36 |
| Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf) | AUCinf will be assessed. | 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. |
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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# 251279 | 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. | |
| 41870065 |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo for ABBV-903 | Drug | Capsule; oral |
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| Itraconazole | Drug | Capsule; oral |
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| Baseline to Day 66 |
| Chowdhury 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. |
| D010879 |
| Piperazines |