Dose escalating PK study of CHR-5154 and CHR-5426
Research type
Research Study
Full title
A Phase 1 double-blind, randomised, placebo-controlled, dose escalating study to assess the safety and tolerability of single and multiple oral doses of CHR-5154 and the effect of the fasted and fed state on pharmacokinetics of CHR-5154 and CHR-5426 in healthy male volunteers.
IRAS ID
134663
Contact name
David J A Bell
Contact email
Sponsor organisation
Chroma Therapeutics Ltd
Eudract number
2013-002197-49
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
A Phase I double-blind, randomised, placebo-controlled, dose escalating study.
The study comprises 2 parts: Part A is a single ascending dose design with a separate food effect arm, and Part B is a multiple ascending dose design.
Up to 64 healthy male volunteers aged 18-45 will be randomised in Part A (SAD phase plus food effect arm), i.e. 8 cohorts of 8 volunteers. Up to 30 healthy male volunteers aged 18-45 will be randomised in Part B (MAD phase), i.e. 3 cohorts of 10 volunteers.
Part A will incorporate sentinel dosing of 2 volunteers in each cohort: 1 on active treatment and 1 on placebo. No further volunteers in each cohort will be dosed until at least 48 hours after dosing the second volunteer, provided that there are no serious or unexplained safety issues as determined by the Investigator.
In Part B all volunteers in each cohort may be dosed simultaneously. Safety and pharmacokinetic data will be reviewed at the Safety Data Review Meetings during Part A and Part B prior to the commencement of the next dose cohort in each part. Part B may commence prior to completion of Part A. The study duration for individual volunteers will be approximately 9 days in Part A and approximately 15 days in Part B, excluding the 30 day screening period. This is the duration from the first visit to the study unit on Day -1 to the post-study medical.
Those volunteers who participate in the food effect phase of Part A will have a second in-house confinement, following a wash-out period, which will be of the same duration as the first, i.e. 3 nights (the second period differs from the first only in that all volunteers will receive active drug and they will also receive a fatty breakfast on Day 1).
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0200
Date of REC Opinion
6 Aug 2013
REC opinion
Favourable Opinion