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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Shoona
Vincent
+44 (0) 7860920432
shoonavincent@macplc.com
Dr
Adhan
Shafiq
-
adhanshafiq@macplc.com
Ms
Hollie
Hulme
+44 (0)1253 444451
holliehulme@macplc.com
Medical condition: Osteoarthritis Medical condition in lay language: In osteoarthritis, the protective cartilage on the ends of the bones breaks down, causing pain, swelling and problems moving the joint. Bony growths develop, and area can become swollen and red Therapeutic areas: Diseases [C] - Musculoskeletal Diseases [C05]
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The purpose of this study is to test a drug called JNJ-39439335 also known as MAVATREP being developed for the treatment of pain. Mavatrep is a potent and selective Transient Receptor Potential Vanilloid cation channel, subfamily V, member 1 (TRPV1) receptor antagonist. The main objectives are to assess the pharmacokinetic profile and the safety and tolerability of the revised capsule formulation of Mavatrep using a placebo-controlled, multiple-dose cohort study in healthy volunteers followed by patients with Osteoarthritis of the knee.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Have occupations or hobbies in which they are at high risk of sustaining thermal burns.2. Previous enrolment and dosing in this or other trials with Mavatrep.3. Received prior treatment with any other TRPV1 antagonist or agonist.4. History of, or current evidence of prolonged QTcF interval >450 msec for male participants or >470 msec for female participants, or a QTcF interval <350 msec, at Screening or Day -1, or a family history of long or short QT syndrome or Torsades de Pointes.5. Significant renal dysfunction, defined as creatinine clearance calculated using the Cockcroft-Gault equation <60 mL/min (Part 1) or <45 mL/min (Part 2).6. Significant suicide risk as defined in the protocol.7. History of malignancy within the past 5 years prior to Screening except for appropriately treated: cutaneous basal cell or squamous cell cancers; cured cervical cancer/cervical cancer in-situ; and (Part 2 only) low-grade stable prostate cancer.8. Known allergies, hypersensitivity, or intolerance to Mavatrep or its excipients.9. Any new or unresolved neurologic deficits, including progressive deficits, within 6 months before Screening. Transient neurologic deficits that are resolved within this period can be allowed if approved by the Investigator.10. History of epilepsy or other seizure disorder.11. Medical history of significant liver insufficiency; chronic hepatitis B or C, or human immunodeficiency virus (HIV), presence of active hepatitis B or C within the past 3 months.12. Clinically relevant history of hypersensitivity, allergy, or contraindication to paracetamol/acetaminophen (or ingredients).13. The participant received botulinum toxin or any other neurotoxin injections within 6 months prior to dosing.14. Active peripheral neuropathy, paraesthesia or dysesthesia, or any other previously diagnosed neurologic condition causing paraesthesia and dysaesthesia.
Patients in Part 2 who meet any of the following additional criteria will be excluded from study participation:15. Has any other chronic pain condition that, in the Investigator’s opinion, would interfere with the patient’s ability to assess their OA pain.16. Any patient with radiographic evidence of another disease which may be contributing to their knee pain (including but not limited to osteonecrosis, severe malalignment, benign or malignant bony lesions) will be excluded.17. Intra-articular injections into the target knee of either corticosteroid (within 3 months of dosing) or hyaluronan (within 1 month of dosing). Intra-articular injections of corticosteroid into any other joint within 1 month of dosing.18. Use of topical capsaicin (e.g., creams, patches) within 1 week of dosing, or intra-articular use of capsaicin within 1 month of dosing.19. History and clinical signs at the target knee joint of any other type of arthropathy (including but not limited to rheumatoid arthritis, psoriatic arthritis, septic arthritis, gout, pseudogout, metabolic and autoimmune arthropathies).20. Severe depression as defined by a score of ≥29 on the Beck Depression Inventory®–II (BDI-II) at Screening.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Shoona
Vincent
+44 (0) 7860920432
shoonavincent@macplc.com
Dr
Adhan
Shafiq
-
adhanshafiq@macplc.com
Ms
Hollie
Hulme
+44 (0)1253 444451
holliehulme@macplc.com
The study is sponsored by MAC Clinical Research and funded by Early Phase Services Limited.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
