Study with Single and Multiple Ascending Doses and Food Effect of JZP505 in Healthy Participants
Research type
Research Study
Full title
A Phase 1, First-in-Human, Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, and Pharmacokinetic Study with Single and Multiple Ascending Doses and Food Effect of JZP505 in Healthy Adult Participants
IRAS ID
1006698
Contact name
Justyna Rooney
Contact email
Sponsor organisation
GW Research Ltd.
ISRCTN Number
ISRCTN40371122
Research summary
This study will assess the pharmacokinetics(PK) (how the drug is absorbed, metabolized, distributed and excreted by the body), safety and tolerability of single and multiple doses of JZP505; the effect of food on PK will also be assessed. \nJZP505 is an oral solution which is similar to cannabidiol (CBD), developed for treatment resistant developmental epilepsy disorders including Lennox–Gastaut Syndrome, Dravet Syndrome and Tuberous sclerosis complex. In these patients, antiepileptic drugs provide only partial relief from seizures, associated with intolerable side effects.\nThis study will be conducted in 2 parts:- single ascending dose (SAD) with a food effect cohort and multiple ascending dose (MAD). Approximately 96 healthy participants aged 18 to 55 years will be enrolled in up to 7 cohorts in the SAD part (cohorts A1 to A7) and 5 cohorts in the MAD part (Cohorts B1 to B5). Each cohort will consist of 8 participants (with at least 1 female participant) receiving JZP505 or placebo in a 3:1 ratio. \nCohorts A1 to A3 will receive single doses of JZP505/Placebo in the fasted state. In Cohort A2, each participant will be dosed in a fasted state and then after a high fat breakfast separated by a minimum of 16 days as part of a food effect evaluation. Cohorts A4 to A7 may be dosed fasted or possibly fed (pending review of safety, tolerability and PK data from Cohort A2). \nThe MAD part of the study will commence if considered appropriate after review of the safety and PK data from Cohorts A1 to A3. The treatment schedule will be once (or twice for cohort B5) a day dosing of JZP505/placebo for 7 days in the fasted or fed state. This schedule may be altered after reviewing PK and safety data from A1 to A3 cohorts; dose frequency will be no more than twice per day and the dosing duration will be no more than 14 days. \nParticipants will be enrolled for 6 to 8 weeks.\nJZP505 is a synthetically derived new chemical entity, with some structural similarity to CBD.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0850
Date of REC Opinion
19 Jan 2023
REC opinion
Further Information Favourable Opinion