Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers

Phase 1 Completed 40 enrolled Biosplice Therapeutics, Inc.

RandomizedParallel-groupOpen-labelOther

Summary

This study will be an open-label, parallel-arm study to determine if a prior intra-articular (IA) injection of lorecivivint (LOR) affects the safety, tolerability, and/or pharmacokinetics (PK) of a subsequent IA injection of the corticosteroid triamcinolone acetonide (TA) into the same knee, and to determine if a prior IA injection of TA affects the safety or tolerability of a subsequent IA injection of LOR into the same knee.

Timeline

Start: 2020-10-13
Primary completion: 2020-12-22
Completion: 2020-12-22

Publications

Fineman MS, McAlindon TE, Lattermann C, Swearingen CJ, Kennedy S, Lopez VA, Simsek I, Tambiah JRS, Yazici Y. Safety, Tolerability, and Pharmacokinetics of Same-Knee Intra-Articular Injection of Corticosteroid and Lorecivivint Within 7 Days: An Open-Label, Randomized, Parallel-Arm Study. Rheumatol Ther. 2023 Dec;10(6):1741-1752. doi: 10.1007/s40744-023-00604-7. Epub 2023 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lorecivivint	Small molecule	0.07 mg	Other
Subject	Triamcinolone Acetonide	Other / unclassified	40 mg	Other

Indications

No indication recorded.