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

Phase 1

Completed

• Conditions: Drug-Drug Interaction
• Interventions: Drug: Lorecivivint (LOR); Drug: Triamcinolone acetonide (TA)

• Registration Number: NCT04598542
• Lead Sponsor: Biosplice Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-06
• Study Start: 2020-10-13
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Primary Completion: 2020-12-22
• Study Completion: 2020-12-22
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Males and females between 18 and 55 years of age, inclusive, in general good health
2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at Screening
3. Negative drug test for amphetamine, cocaine, methadone, opiates, phencyclidine (PCP), barbiturates, benzodiazepines, tricyclic antidepressants, and marijuana

Key

Exclusion Criteria

1. Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at the Screening Visit or Day -1
2. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control during the study period
3. Men who are sexually active and of reproductive potential, who have partners who are capable of becoming pregnant, and who are not willing to use birth control during the study period
4. Any chronic medical condition that requires medication
5. Any history of IA injection, surgery (e.g., arthroscopy), infection, major orthopedic injury, or inflammatory rheumatic diseases (e.g., rheumatoid arthritis, gout, pseudogout) of either knee
6. Any contraindications for an IA injection in the right knee in the opinion of the Investigator
7. Previous treatment with lorecivivint (LOR)
8. Treatment with any glucocorticoids (oral, intravenous, intramuscular, IA, topical, or inhaled) within 12 weeks before Day 1
9. Consumption of grapefruit, grapefruit juice, Seville oranges, or vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts) within 10 days before Day 1
10. Known hypersensitivity to triamcinolone acetonide (TA)
11. Significant blood loss (> 500 mL) or donation of blood within 30 days of screening
12. Regular use of nicotine-containing products, including, but not limited to, cigarettes, e-cigarettes, or nicotine gum or patches
13. Any condition, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
14. Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease (MDRD) equation at the Screening Visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TA injection followed by LOR injection	Triamcinolone acetonide (TA)	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	Lorecivivint (LOR)	IA injection of LOR into the right knee, followed by IA injection of TA into the same knee 7 days later.
LOR injection followed by TA injection	Triamcinolone acetonide (TA)	IA injection of LOR into the right knee, followed by IA injection of TA into the same knee 7 days later.
TA injection followed by LOR injection	Lorecivivint (LOR)	IA injection of TA into the right knee, followed by IA injection of LOR into the same knee 7 days later.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Miami, Florida, United States