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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598542
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

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.

Condition or disease Intervention/treatment Phase
Drug-Drug Interaction Drug: Lorecivivint (LOR) Drug: Triamcinolone acetonide (TA) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : October 13, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: TA injection followed by LOR injection
IA injection of TA into the right knee, followed by IA injection of LOR into the same knee 7 days later.
Drug: Lorecivivint (LOR)
0.07 mg
Other Name: SM04690

Drug: Triamcinolone acetonide (TA)
40 mg

Experimental: LOR injection followed by TA injection
IA injection of LOR into the right knee, followed by IA injection of TA into the same knee 7 days later.
Drug: Lorecivivint (LOR)
0.07 mg
Other Name: SM04690

Drug: Triamcinolone acetonide (TA)
40 mg




Primary Outcome Measures :
  1. Cmax of LOR [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration ]
  2. AUC 0-last of LOR [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration ]
  3. Plasma concentration profiles of LOR [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration ]
  4. Cmax of TA [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration ]
  5. AUC 0-last of TA [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration ]
  6. Plasma concentration profiles of TA [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598542


Contacts
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Contact: Samumed Clinical Trials 1-855-222-0515 clinicaltrials@samumed.com

Locations
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United States, Florida
Research Site Recruiting
Miami, Florida, United States, 33126
Sponsors and Collaborators
Samumed LLC
Investigators
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Study Director: Yusuf Yazici, M.D. Samumed LLC
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Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT04598542    
Other Study ID Numbers: SM04690-OA-16
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samumed LLC:
lorecivivint
triamcinolone acetonide
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action