Phase I trials have been completed in healthy Japanese and Caucasian volunteers.[1][2]
Potential common
adverse effects include thermohypoesthesia, chills, feeling cold, and feeling hot.[2]
Pharmacokinetics
When administered orally once a day, mavatrep reached
steady-state in healthy volunteers in approximately 14 days.[2] It has a relatively long half life between 68 and 101 hours in Japanese subjects and between 82 and 130 hours in Caucasian subjects.[2]
Mavatrep is largely eliminated nonrenally. Mavatrep appears to be metabolized into two primary metabolites which are also eliminated nonrenally.[2]
^
abManitpisitkul P, Shalayda K, Russell L, Sanga P, Williams Y, Solanki B, et al. (September 2018). "Bioavailability and Pharmacokinetics of TRPV1 Antagonist Mavatrep (JNJ-39439335) Tablet and Capsule Formulations in Healthy Men: Two Open-Label, Crossover, Single-Dose Phase 1 Studies". Clinical Pharmacology in Drug Development. 7 (7): 699–711.
doi:
10.1002/cpdd.412.
PMID29125700.
S2CID32666782.
^
abcdeManitpisitkul P, Shalayda K, Russell L, Sanga P, Solanki B, Caruso J, et al. (September 2018). "Pharmacokinetics and Safety of Mavatrep (JNJ-39439335), a TRPV1 Antagonist in Healthy Japanese and Caucasian Men: A Double-Blind, Randomized, Placebo-Controlled, Sequential-Group Phase 1 Study". Clinical Pharmacology in Drug Development. 7 (7): 712–726.
doi:
10.1002/cpdd.413.
PMID29125703.
S2CID11755963.