Safety, tolerability and PK, of SAD and MAD of XEN1101 in HV
Research type
Research Study
Full title
Phase 1, First-in-human, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN1101 and Single Dose Preliminary Open-label Pharmacodynamic Assessment in Healthy Subjects Addendum Title: Phase 1, randomised, multi part study to evaluate the safety, tolerability, pharmacokinetics, relative bioavailability and food effect of single and multiple ascending doses of XEN1101 and Preliminary Drug-Drug Interaction Assessment with Itraconazole
IRAS ID
233152
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Xenon Pharmaceuticals Inc.
Eudract number
2017-003168-11
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
XPF-008 is an investigational drug under development for the treatment of epilepsy (focal seizures).
This First-In-Human trial will comprise two parts; Single Ascending (Part I) and Multiple Ascending Oral Doses (Part II) given to healthy male and female volunteers aged 18 to 55. Part I will be further separated into Parts Ia and Ib, where eligible male volunteers who completed Part Ia continue into Part Ib.
Parts Ia and II will investigate safety, tolerability and how long XPF-008 stays in blood (Pharmacokinetics). Part Ib will evaluate the potential effects on the body (Pharmacodynamics) of XPF-008 using Transcranial Magnetic stimulation (TMS).
In Part Ia up to eight cohorts (maximum total 60 volunteers) are planned with planned ascending doses from 5mg. Volunteers will be randomised to active drug or placebo in a 3:1 ratio. Volunteers will be admitted to the study unit on Day-1, dosed on Day 1 and discharged on Day 2and attend the unit for an outpatient visit on Day 7, with a follow-up phone-call on Day 30 (unless continuing to Part 1b).
In Part Ib, up to 12 male volunteers who received active drug and completed Part Ia, will be admitted to the TMS unit and receive a further single dose of XPF-008. TMS will be used to monitor any effect. They will be discharged on Day 2, attend an outpatient visit on Day 7, with a follow-up phone-call on Day 30.
In Part II up to five cohorts (maximum total 40 volunteers) are planned. Volunteers will be randomised to receive active drug or placebo in 3:1 ratio. Volunteers will be admitted to the study unit on Day -1, dosed on Days 1-7, and discharged on Day 9. All volunteers will attend the unit for an outpatient visit on Day 14 and receive a follow-up phone-call on Day 37.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0413
Date of REC Opinion
28 Sep 2017
REC opinion
Further Information Favourable Opinion