BioA study to compare ZN-A-1041 Tablet and Capsule formulations and food and PPI effects on PK
Research type
Research Study
Full title
A PHASE 1, OPEN-LABEL, RANDOMIZED, CROSSOVER, TWO-PART STUDY TO EVALUATE THE RELATIVE BIOAVAILABILITY OF TWO ZN-A-1041 TABLET FORMULATIONS COMPARED TO CAPSULE FORMULATION AND THE EFFECT OF FOOD AND PROTON PUMP INHIBITOR ON THE PHARMACOKINETICS OF ZN-A-1041 TABLET IN HEALTHY SUBJECTS
IRAS ID
1010711
Contact name
Head of CTRM Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd.
Research summary
This is an open-label crossover study to compare the absorption of tablet and capsule formulations of the study drug (ZN-A-1041), while testing the effects of food and proton pump inhibitor (PPI). ZN-A-1041 is an experimental drug being developed for the treatment of certain cancers. Part 1 will compare the absorption of immediate release (IR) tablets and modified release (MR) tablets while fasted, relative to MR capsules. The formulation with the best absorption profile will be selected for part 2. Part 1 will require at least 15 participants. The treatment arms for part 1 include: A 800mg in MR capsules; B 800mg in IR tablets; C 800mg in MR tablets. Each treatment will be given orally after fasting for 8 hours. Participants will be assigned a random treatment arm and will cross-over to each other treatment arm. Participants will be resident in clinic from day-1 to day 12 with dosing periods occurring on days 1, 5, and 9. There will be a follow-up phone call 7-10 days after last dose.
Part 2 will study the absorption of the selected formulation with food and PPI effects. Part 2a will compare the fed and fasted states only. Part 2b will compare fed and fasted states in the presence of the PPI rabeprazole. Part 2 will require at least 20 participants. The treatment arms for part 2 include: D 800mg fasted; E 800mg with high fat meal 30 mins before study drug; F 20mg rabeprazole twice a day for two days followed by 20mg of rabeprazole plus 800mg study drug on the third day while fasted; G as per F but with high fat meal 30 mins before study drug. Participants will be assigned either D or E as their initial treatment and will cross-over to each other treatment arm. Participants will be resident in clinic from day-1 to day 20, with study drug dosing periods at days 1, 5, 11 and 17. PPI treatment arms will always be the final two cross overs so that participants remain resident during their PPI initiation. There will be a follow-up phone call 7-10 days after last dose.REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0003
Date of REC Opinion
18 Feb 2025
REC opinion
Further Information Favourable Opinion