Drug-Drug InteractionPhase 1NCT04598542
Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers
A Phase 1 study testing Lorecivivint (LOR) and Triamcinolone acetonide (TA) in people with Drug-Drug Interaction, run by Biosplice Therapeutics, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-Drug Interaction
- What is being tested?
- Lorecivivint (LOR) and Triamcinolone acetonide (TA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2020to 22 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between 18 and 55 years of age, inclusive, in general good health
- Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at Screening
- Negative drug test for amphetamine, cocaine, methadone, opiates, phencyclidine (PCP), barbiturates, benzodiazepines, tricyclic antidepressants, and marijuana
Who cannot join
- 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
- 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
- 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
- Any chronic medical condition that requires medication
- 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
- Any contraindications for an IA injection in the right knee in the opinion of the Investigator
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- Previous treatment with lorecivivint (LOR)
- Treatment with any glucocorticoids (oral, intravenous, intramuscular, IA, topical, or inhaled) within 12 weeks before Day 1
- 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
- Known hypersensitivity to triamcinolone acetonide (TA)
- Significant blood loss (> 500 mL) or donation of blood within 30 days of screening
- Regular use of nicotine-containing products, including, but not limited to, cigarettes, e-cigarettes, or nicotine gum or patches
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Drug-Drug Interaction
- Being tested
- Lorecivivint (LOR), Triamcinolone acetonide (TA)
- Keywords
- lorecivivint, triamcinolone acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lorecivivint (LOR)Drug
Also called SM04690
0.07 mg
Triamcinolone acetonide (TA)Drug
40 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lorecivivint (LOR); Drug: Triamcinolone acetonide (TA) |
| 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. Receives: Drug: Lorecivivint (LOR); Drug: Triamcinolone acetonide (TA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of LOR
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
AUC 0-last of LOR
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
Plasma concentration profiles of LOR
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
Cmax of TA
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
AUC 0-last of TA
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
Plasma concentration profiles of TA
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start13 Oct 2020
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug-Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusuf Yazici, M.D., Study director, Biosplice Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598542
- Sponsor's protocol ID
- SM04690-OA-16
- Status last verified
- Jan 2021
- First submitted
- 6 Oct 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37902943
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04598542
- Acronym / sponsor ID
- SM04690-OA-16
- Conditions
- Drug-Drug Interaction
- Keywords
- lorecivivint, triamcinolone acetonide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TA injection followed by LOR injection | Experimental | Drug: Lorecivivint (LOR), Drug: 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 | Experimental | Drug: Lorecivivint (LOR), Drug: Triamcinolone acetonide (TA)IA injection of LOR into the right knee, followed by IA injection of TA into the same knee 7 days later. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females between 18 and 55 years of age, inclusive, in general good health
- Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at Screening
- Negative drug test for amphetamine, cocaine, methadone, opiates, phencyclidine (PCP), barbiturates, benzodiazepines, tricyclic antidepressants, and marijuana
Key exclusion criteria (14 listed)
- 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
- 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
- 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
- Any chronic medical condition that requires medication
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lorecivivint (LOR)Also: SM046900.07 mg | Drug | LOR injection followed by TA injection, TA injection followed by LOR injection |
| Triamcinolone acetonide (TA)40 mg | Drug | LOR injection followed by TA injection, TA injection followed by LOR injection |
Primary outcome
Cmax of LOR
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
AUC 0-last of LOR
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
Plasma concentration profiles of LOR
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration
Cmax of TA
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
AUC 0-last of TA
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
Plasma concentration profiles of TA
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 96 hours after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Derived from this study: PubMed 37902943Fineman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuf Yazici, M.D. study director
Biosplice Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lorecivivint (LOR) and Triamcinolone acetonide (TA) in people with Drug-Drug Interaction, run by Biosplice Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of LOR (time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 hours after administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598542, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.