Phase 1 PK study in healthy subjects (QSC118240)
Research type
Research Study
Full title
A Phase 1, Single-Part, Open-Label, 5-Period Study Designed to Evaluate the Pharmacokinetic Profile of Sulfasalazine Following Single Dose Administration of ZX112 Prototype Oral Formulations in Healthy Volunteers
IRAS ID
247040
Contact name
Sharan Sidhu
Contact email
Sponsor organisation
Zogenix Inc.
Eudract number
2018-001913-34
Duration of Study in the UK
0 years, 3 months, 11 days
Research summary
The Sponsor is developing the test medicine, ZX112, for the potential treatment of central nervous system (CNS) conditions. CNS conditions affect the brain and spinal cord (which control the function of the body and pass signals to and from the brain and body).\n\nThe study is designed to identify the level of study drug present in the blood, as well as to look at the safety and tolerability of the test medicine.\n\nThe study will consist of 5 study periods involving up to 24 healthy male and female volunteers. Twenty-four volunteers will be enrolled to participate in Periods 1 and 2. On admission the volunteers will be randomly assigned to receive 1 of 12 treatment sequences, where they will receive one dose of the study drug at each period. Twelve volunteers will be selected from Periods 1 and 2 to continue into Periods 3, 4 and 5; the volunteers will receive one dose of the study drug at each period. For all periods, volunteers will be dosed on Day 1 and be discharged on Day 3. The volunteers will attend a return visit on Day 4 and 5 for additional blood samples. There will be a break of at least 5 days between each period. There will be a follow up phone call 5 to 7 day’s post-final dose to ensure the ongoing wellbeing of the volunteers. Any volunteers who are not selected to proceed into Period 3 will have a follow up phone call between 5 to 7 days following dosing of Period 3.\n
REC name
HSC REC B
REC reference
18/NI/0137
Date of REC Opinion
15 Aug 2018
REC opinion
Favourable Opinion