A Phase I, Single and Multiple Dose Study
Research type
Research Study
Full title
PXT002331 - A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects
IRAS ID
196088
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Prexton Therapeutics
Eudract number
2015-004697-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 23 days
Research summary
PXT002331 is an investigational medication which will be tested in humans for the first time.\n\nThis study consists of 2 parts. This study will be double-blind (neither the volunteers nor the investigator will know who has study drug) and placebo (dummy medication) controlled. Which participants receive PXT002331 or placebo will be determined randomly.\n\n\nPart A\n48 healthy volunteers (Male and female) will be enrolled in 6 groups, with each group consisting of 8 volunteers (6 receiving the Study Drug, 2 receiving placebo). If emerging data indicate that further dose levels are necessary to achieve study objectives, up to a further 3 groups will be conducted. \n\nEach volunteer will have only one dose of PXT002331 or placebo and reside at the clinical research unit (CRU) from Day -1 (day before dosing) to Day 3 except in Group A4 where each volunteer will participate in 2 treatment periods (one dose on each occasion. The first treatment period to be dosed fasted, the second treatment period to be dosed after eating a high fat breakfast) separated by a minimum of 6 days between doses. In each group, 2 volunteers will be dosed 24 hours before the remaining 6 volunteers. Volunteers will attend a Post-study visit, 5 to 7 days after their final dose. \n\nThe planned Dose Levels are 20, 50, 125, 250, 500, and 1000 mg.\n\nPart B\n24 healthy volunteers (male and female) will be studied in 3 groups, each group consisting of 8 volunteers. If emerging data indicate that a fourth group is necessary to achieve study objectives, it will be conducted in the same manner as the previous completed groups.\n \nEach volunteer will participate in 1 treatment period and reside at the CRU from Day -1 until the morning of Day 16. Volunteers will attend a post-study visit, 5 to 7 days after their final dose. Each volunteer will receive 14 daily doses (twice daily on Day 1 to 13 and a single dose on Day 14). Doses may be altered if considered necessary based on Part A results. Dose level will be confirmed following completion of part A.\n
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0002
Date of REC Opinion
22 Jan 2016
REC opinion
Further Information Favourable Opinion