Phase 1, PK and Safety Investigating Mavatrep in HV and OA knee.
Research type
Research Study
Full title
A Phase 1, Randomised, Double-Blind, Placebo-Controlled Study Investigating the Pharmacokinetics, Safety and Tolerability of Multiple Ascending Doses of a Revised Capsule Formulation of JNJ 39439335 (Mavatrep) in Healthy Participants and Patients with Knee Pain from Osteoarthritis
IRAS ID
1008026
Contact name
Shoona Vincent
Contact email
Sponsor organisation
Early Phase Services
ISRCTN Number
ISRCTN77911445
Research summary
The purpose of this study is to test a drug called JNJ-39439335 also known as MAVATREP that is 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.
Main objectives are to assess the PK profile and the safety and tolerability for 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.
Up to 24 male and female healthy volunteers between the ages of 18 and 55 followed by 6 male and female participants between the ages of 25 and 79 with osteoarthritis of the knee will be included in this trial.
Multiple-dose administration of Mavatrep or placebo will occur for 21 consecutive days. A loading dose is planned to be administered twice-daily on Day 1 and Day 2 while the participant remains at site, followed by 19 days of once daily administration of Mavatrep or placebo with a mixture of self administration at home and site visits which include overnight stays for PK monitoring. The placebo and Mavatrep groups will both take the same amount of capsules.
REC name
Wales REC 1
REC reference
24/WA/0305
Date of REC Opinion
17 Dec 2024
REC opinion
Further Information Favourable Opinion