Clinical trial NCT04598542: Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-Drug Interaction
Keywords: lorecivivint
triamcinolone acetonide
Lead sponsor: Biosplice Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Key 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

Primary outcomes:
measure: Cmax of LOR
timeFrame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
measure: AUC 0-last of LOR
timeFrame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
measure: Plasma concentration profiles of LOR
timeFrame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
measure: Cmax of TA
timeFrame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
measure: AUC 0-last of TA
timeFrame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
measure: Plasma concentration profiles of TA
timeFrame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Research Site
state: Florida
Study officials:
affiliation: Biosplice Therapeutics, Inc.
name: Yusuf Yazici, M.D.
role: STUDY_DIRECTOR
References: