A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989

NCT04208386 ↗

Phase 1 Completed 16 enrolled Janssen Sciences Ireland UC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate the single-dose pharmacokinetic (PK) of JNJ-73763976 and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in participants with liver cirrhosis and various degrees of impaired hepatic function when compared with healthy participants with normal hepatic function and no liver cirrhosis.

Timeline

Start: 2020-01-08
Primary completion: 2020-07-20
Completion: 2020-07-20

Publications

Kakuda TN, Halabi A, Klein G, Sanga M, Guinard-Azadian C, Kowalik M, Nedoschinsky K, Nangosyah J, Ediage EN, Hillewaert V, Verboven P, Goris I, Snoeys J, Palmer M, Biermer M. Pharmacokinetics of JNJ-73763989 and JNJ-56136379 (Bersacapavir) in Participants With Moderate Hepatic Impairment. J Clin Pharmacol. 2023 Jun;63(6):732-741. doi: 10.1002/jcph.2214. Epub 2023 Mar 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-73763989	Small interfering RNA (siRNA)	200 mg	Subcutaneous

Indications

No indication recorded.