Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA injection followed by LOR injection | Experimental | IA injection of TA into the right knee, followed by IA injection of LOR into the same knee 7 days later. |
|
| LOR injection followed by TA injection | Experimental | IA injection of LOR into the right knee, followed by IA injection of TA into the same knee 7 days later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorecivivint (LOR) | Drug | 0.07 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of LOR | 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration | |
| AUC 0-last of LOR | 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration | |
| Plasma concentration profiles of LOR | 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration | |
| Cmax of TA | 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration | |
| AUC 0-last of TA | 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration | |
| Plasma concentration profiles of TA | 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yusuf Yazici, M.D. | Biosplice Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Miami | Florida | 33126 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37902943 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000627701 | lorecivivint |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Triamcinolone acetonide (TA) | Drug | 40 mg |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |