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

Drug-Drug Interaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598542
• Other study ID #: SM04690-OA-16
• Status: Completed
• Phase: Phase 1
• Start date: October 13, 2020
• Est. completion date: December 22, 2020

Study information

• Verified date: January 2021
• Source: Samumed LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug-Drug Interaction

Intervention

Drug:
• Lorecivivint (LOR)
0.07 mg
• Triamcinolone acetonide (TA)
40 mg

Locations

Country	Name	City	State
United States	Research Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Samumed LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of LOR		0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
Primary	AUC 0-last of LOR		0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
Primary	Plasma concentration profiles of LOR		0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
Primary	Cmax of TA		0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
Primary	AUC 0-last of TA		0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
Primary	Plasma concentration profiles of TA		0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration