[Tc-99m]-RPI-087 as an Imaging Marker in Osteoarthritis of the Knee Compared to Healthy Volunteers

Launched by REILEY PHARMACEUTICALS INC. · Apr 11, 2018

Keywords

ClinConnect Summary

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, urinal...

Gender

ALL

Eligibility criteria

• Inclusion Criteria :
• • 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.
• 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.
• Exclusion Criteria:
• • 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.
• • 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.