A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults

Phase 1 Completed 104 enrolled AbbVie

RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start: 2023-01-03
Primary completion: 2023-10-23
Completion: 2023-10-23

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.
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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABBV-903	Unknown	50 mg	Oral
Subject	ABBV-903	Unknown	200 mg	Oral
Subject	ABBV-903	Unknown	400 mg	Oral
Subject	ABBV-903	Unknown	800 mg	Oral
Subject	Itraconazole	Small molecule	200 mg	Oral

Indications

No indication recorded.