HealthyPhase 1NCT03503825
[Tc-99m]-RPI-087 as an Imaging Marker in Osteoarthritis of the Knee Compared to Healthy Volunteers
A Phase 1 study testing [Tc-99m]-RPI-T-087 Injection in people with Healthy and Osteo Arthritis Knee, run by Reiley Pharmaceuticals Inc. at 1 site in Canada.
Trial summary
The main purpose of this study is to test the safety and tolerability of T-087. The study will enroll 6 healthy volunteers (HVs) and 6-18 subjects with KOA. All eligible subjects will receive an intravenous injection of the radioactive investigational product (ip) (T-087), followed by SPECT/CT imaging of the knees and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Osteo Arthritis Knee
- What is being tested?
- [Tc-99m]-RPI-T-087 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 16 Aug 2018to 30 Jun 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects must be able to read and speak in English and capable of giving signed informed consent.
- Female subjects must either, not be of reproductive potential, or not be pregnant and be willing to comply with appropriate family planning methods as specified in the protocol.
- Male subjects must either, not be of reproductive potential or be willing to comply with appropriate family planning methods as specified in the protocol.
- Subjects with Knee Osteoarthritis (KOA)
- Age ≥ 40 to ≤ 70 years, at the time of signing the informed consent
- Have chronic pain due to OA of at least one knee identifiable as the target knee as their primary pain condition and some degree of pain every day from this condition.
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- For Healthy Volunteers:
- Age ≥ 18 to ≤ 35 years, at the time of signing the informed consent.
- No history of knee pain or known knee pathology confirmed by knee radiographs, obtained within the last year.
Who cannot join
- Chronic pain conditions other than OA of the knee (KOA) as their predominant pain condition
- Cannot or will not agree to stop: all topical, oral and parenteral non-steroidal anti-inflammatory drugs (NSAIDs) for at least 48 hours before administration of the IP; stop turmeric and curcumin (supplements and dietary sources) for at least 48 hours before administration of the IP; avoid all exercise from at least 24 hours before administration of the IP up to the end of the last applicable imaging session.
- Systemic (including inhaled) and oral corticosteroid use currently or within 6 weeks prior to Visit 1.
- Surgical interventions of either knee or any other major surgery within the previous 6 months.
- Receipt of intra-articular corticosteroid injections within the previous 6 weeks prior to Visit 1 in the target knee or within the previous 2 weeks prior to Visit 1 in any other joint.
- Use of any other investigational medication or devices within 30 days prior to Visit 1.
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- Orthopedic or prosthetic appliance in either knee which may confound scan interpretation.
- Screening ECG or laboratory assessments showing clinically significant abnormalities
- Refusal or inability to tolerate the scanning procedures
- Allergies to or cannot tolerate NSAIDs, the investigational product or sulfa drugs
- History of bleeding disorders or history of documented gastrointestinal ulcer disease.
- Received significant ionizing radiation exposure, in the last 12 months or undergoing occupational monitoring for radiation exposure.
- Allergies or sensitivity to any component of the investigational product. Subjects taking disulfiram (Antabuse) should be excluded from this study.
- History of alcohol or substance abuse
- Any medical condition or disease that in the opinion of the investigator makes the subject unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Janet Crouch, RTNM, (905) 522-1155 ext. 35019
MaryLou, RN, (905) 522-1155 ext. 33790
About this study
Official title: A Phase 1, Open-label, Non-Randomized Study to Evaluate the Safety and Tolerability of [Tc-99m]-RPI T-087 Injection as an Imaging Marker for COX-2 in Subjects With Osteoarthritis of the Knee Compared to Healthy Volunteers
The main purpose of this study is to test the safety and tolerability of T-087. The study will enroll 6 healthy volunteers (HVs) and 6-18 subjects with KOA. All eligible subjects will receive an intravenous injection of the radioactive investigational product (ip) (T-087), followed by SPECT/CT imaging of the knees and blood tests and clinical assessments for safety monitoring. Healthy volunteers will also have their whole body imaged and have extra blood drawn to determine where T-087 goes in the body. These additional procedures will be done on the same day as the ip administration, and repeated the following day. All subjects will have a final follow-up phone call within 2- 3 business days following the ip administration.
Read the detailed description
This is a Phase 1, non-randomized, open label, single centre clinical trial. 6 healthy volunteers (3 male and 3 female,4 study visits) and 6-18 subjects with Osteoarthritis of the knee (3 study visits) will be enrolled. At visit 2, all subjects will have knee pain assessed, using a visual analogue scale, prior to receiving a single, 555 MBq (15 mCi)+/-10% dose of [Tc-99m)-RPI-T-087 injection. Knees will be imaged with a SPECT/CT camera at specified time-points post injection. Safety monitoring will include vital signs, ECG, clinical laboratory tests (serum biochemistry, haematology, urinalysis) and adverse event monitoring.
Additionally, HVs will have whole body planar imaging and blood sampling conducted at Visit 2 and 3 to evaluate bio-distribution, estimate dosimetry and measure clearance of total activity over time in blood samples. A final follow-up visit will be conducted by phone interview.
Once 6 HVs and 6 KOA participants have completed the study, a blinded assessment of the image data will be conducted to determine whether any more KOA subjects should be imaged.
- Conditions
- Healthy, Osteo Arthritis Knee
- Being tested
- [Tc-99m]-RPI-T-087 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[Tc-99m]-RPI-T-087 InjectionDrug
Also called T-087
A single intravenous injection of [Tc-99m]-RPI-T-087 followed by SPECT/CT imaging of the knee (all subjects) and whole body planar imaging (Healthy volunteers only)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Healthy volunteers will be administered [Tc-99m]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety, knee image evaluation, and radioactivity biodistribution and dosimetry. Receives: Drug: [Tc-99m]-RPI-T-087 Injection |
| Osteo Arthritis of the knee | Experimental | Subjects with knee osteoarthritis will be administered [Tc-99m]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety and knee image evaluation. Receives: Drug: [Tc-99m]-RPI-T-087 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
The incidence of adverse events, including injection site reactions, clinically significant changes in clinical laboratory parameters (blood and urine), ECG's and vital signs, will be summarized over time to assess safety and tolerability.
Measured: Up to 3 days post investigative product administration
Secondary outcomes (3)
Uptake over time
Quantitative standard uptake values (SUV) for T-087 will be determined for the knees of subjects with KOA and HVs, and comparing uptake in the target knee of OA subjects with the uptake in the knees of the HVs.
Measured: Up to 4.5 hours post administration of the investigational product
Image quality
A visual assessment using a scoring system will be used to assess the SPECT/CT images quality in subjects with KOA. Image quality scales of 1 to 3, with 1 as unacceptable (non-interpretable quality), 2 as adequate quality for interpretation and 3 as excellent quality (no issues) of the target knee will be descriptively summarized by time point and subject group.
Measured: Up to 4.5 hours post administration of the investigational product
Dosimetry
Whole body planar imaging of healthy volunteers will be used to evaluate the biodistribution of [Tc-99m]-RPI-T-087 Injection to estimate dosimetry. Whole body scintigraphic images will be quantified as to fractional activity (IA) in various visceral organs (e.g., liver, lungs, heart) as well as routes of excretion, total body and knees. The data describing the uptake, retention and clearance in these tissues will characterize the biodistribution and biokinetics of the IP. These data also serve as the foundation for radiation dose estimates for the IP.
Measured: Up to 1 day post administration of the investigational product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start16 Aug 2018
- Primary completion31 May 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase 1, non-randomized, open-label, single-centre clinical trial. A total of 12 to 24 subjects will be enrolled: * 6 Healthy volunteers (HV) (3 males and 3 females) * 6 - 18 subjects with osteoarthritis of the knee (KOA) Once 6 HVs and 6 KOA subjects (to be enrolled concurrently) have completed the study, image data will be assessed to determine whether any more KOA subjects should be imaged.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reiley Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Gulenchyn, MD, Principal investigator, St. Joseph's Hospital Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503825
- Sponsor's protocol ID
- RPI-T-087-001
- Status last verified
- Jan 2019
- First submitted
- 6 Apr 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Non-Randomized Study to Evaluate the Safety and Tolerability of [Tc-99m]-RPI T-087 Injection as an Imaging Marker for COX-2 in Subjects With Osteoarthritis of the Knee Compared to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03503825
- Acronym / sponsor ID
- RPI-T-087-001
- Conditions
- Healthy, Osteo Arthritis Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Reiley Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 20 Apr 2018 (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.
The main purpose of this study is to test the safety and tolerability of T-087. The study will enroll 6 healthy volunteers (HVs) and 6-18 subjects with KOA. All eligible subjects will receive an intravenous injection of the radioactive investigational product (ip) (T-087), followed by SPECT/CT imaging of the knees and blood tests and clinical assessments for safety monitoring. Healthy volunteers will also have their whole body imaged and have extra blood drawn to determine where T-087 goes in the body. These additional procedures will be done on the same day as the ip administration, and repeated the following day. All subjects will have a final follow-up phone call within 2- 3 business days following the ip administration.
Detailed description
This is a Phase 1, non-randomized, open label, single centre clinical trial. 6 healthy volunteers (3 male and 3 female,4 study visits) and 6-18 subjects with Osteoarthritis of the knee (3 study visits) will be enrolled. At visit 2, all subjects will have knee pain assessed, using a visual analogue scale, prior to receiving a single, 555 MBq (15 mCi)+/-10% dose of [Tc-99m)-RPI-T-087 injection. Knees will be imaged with a SPECT/CT camera at specified time-points post injection. Safety monitoring will include vital signs, ECG, clinical laboratory tests (serum biochemistry, haematology, urinalysis) and adverse event monitoring.
Additionally, HVs will have whole body planar imaging and blood sampling conducted at Visit 2 and 3 to evaluate bio-distribution, estimate dosimetry and measure clearance of total activity over time in blood samples. A final follow-up visit will be conducted by phone interview.
Once 6 HVs and 6 KOA participants have completed the study, a blinded assessment of the image data will be conducted to determine whether any more KOA subjects should be imaged.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Phase 1, non-randomized, open-label, single-centre clinical trial. A total of 12 to 24 subjects will be enrolled: * 6 Healthy volunteers (HV) (3 males and 3 females) * 6 - 18 subjects with osteoarthritis of the knee (KOA) Once 6 HVs and 6 KOA subjects (to be enrolled concurrently) have completed the study, image data will be assessed to determine whether any more KOA subjects should be imaged.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: [Tc-99m]-RPI-T-087 InjectionHealthy volunteers will be administered [Tc-99m]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety, knee image evaluation, and radioactivity biodistribution and dosimetry. |
| Osteo Arthritis of the knee | Experimental | Drug: [Tc-99m]-RPI-T-087 InjectionSubjects with knee osteoarthritis will be administered [Tc-99m]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety and knee image evaluation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All subjects must be able to read and speak in English and capable of giving signed informed consent.
- Female subjects must either, not be of reproductive potential, or not be pregnant and be willing to comply with appropriate family planning methods as specified in the protocol.
- Male subjects must either, not be of reproductive potential or be willing to comply with appropriate family planning methods as specified in the protocol.
- Subjects with Knee Osteoarthritis (KOA)
- Age ≥ 40 to ≤ 70 years, at the time of signing the informed consent
Key exclusion criteria (15 listed)
- Chronic pain conditions other than OA of the knee (KOA) as their predominant pain condition
- Cannot or will not agree to stop: all topical, oral and parenteral non-steroidal anti-inflammatory drugs (NSAIDs) for at least 48 hours before administration of the IP; stop turmeric and curcumin (supplements and dietary sources) for at least 48 hours before administration of the IP; avoid all exercise from at least 24 hours before administration of the IP up to the end of the last applicable imaging session.
- Systemic (including inhaled) and oral corticosteroid use currently or within 6 weeks prior to Visit 1.
- Surgical interventions of either knee or any other major surgery within the previous 6 months.
- Receipt of intra-articular corticosteroid injections within the previous 6 weeks prior to Visit 1 in the target knee or within the previous 2 weeks prior to Visit 1 in any other joint.
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 |
|---|---|---|
| [Tc-99m]-RPI-T-087 InjectionAlso: T-087A single intravenous injection of [Tc-99m]-RPI-T-087 followed by SPECT/CT imaging of the knee (all subjects) and whole body planar imaging (Healthy volunteers only) | Drug | Healthy Volunteers, Osteo Arthritis of the knee |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: Up to 3 days post investigative product administration
The incidence of adverse events, including injection site reactions, clinically significant changes in clinical laboratory parameters (blood and urine), ECG's and vital signs, will be summarized over time to assess safety and tolerability.
3 secondary outcomes
Uptake over time
Time frame: Up to 4.5 hours post administration of the investigational product
Image quality
Time frame: Up to 4.5 hours post administration of the investigational product
Dosimetry
Time frame: Up to 1 day post administration of the investigational product.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Karen Gulenchyn, MD principal investigator
St. Joseph's Hospital Hamilton
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 [Tc-99m]-RPI-T-087 Injection in people with Healthy and Osteo Arthritis Knee, run by Reiley Pharmaceuticals Inc. at 1 site in Canada.
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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 15 Jan 2019. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janet Crouch, BScc, MRT(N) ((905) 522-1155 ext. 35019, jcrouch@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (time frame: Up to 3 days post investigative product administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2019.