NCT04598542

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

Open-Label, Parallel-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Corticosteroid Intra Articular Injection Given 7 Days Before or 7 Days After Lorecivivint Intra-articular Injection Into the Knee of Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug-Drug Interaction

Interventions

Type	Name	Description
DRUG	Lorecivivint (LOR)	0.07 mg
DRUG	Triamcinolone acetonide (TA)	40 mg

Timeline

• Start date: 2020-10-13
• Primary completion: 2020-12-22
• Completion: 2020-12-22
• First posted: 2020-10-22
• Last updated: 2021-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study