Relative Bioavailability of Alectinib Tablet (QSC205441/JP43291)
Research type
Research Study
Full title
A Two Part, Four Way Crossover, Randomised, Open-Label Study Designed to Evaluate the Relative Bioavailability of Novel Oral Alectinib Tablet Formulations Compared with Oral Reference Alectinib Capsule, in the Fasted and Fed State in Healthy Subjects
IRAS ID
306461
Contact name
Morihiko Hayashi
Contact email
Sponsor organisation
Chugai Pharma Europe Ltd.
Eudract number
2021-005346-14
ISRCTN Number
ISRCTN74516835
Duration of Study in the UK
0 years, 2 months, 12 days
Research summary
Summary of Research \n\nBackground and study aims\nThe Sponsor is investigating the development of new formulations of the test medicine, alectinib, as an oral formulation for the potential treatment of cancer in children. This healthy volunteer study is testing how four different formulations of the test medicine are taken up by the body over time (the pharmacokinetics) and the proportion of test medicine that enters the bloodstream (relative bioavailability). It is also looking to assess the safety and tolerability of the test medicine and assess its swallowability and the impact of food on the test medicine.\n \nWho can participate?\nHealthy male and non-pregnant, non-lactating female volunteers of non-childbearing potential aged 18 to 55 years.\n \nWhat does the study involve?\nThe study consists of 2 parts, each consisting of 4 study periods, involving up to 32 healthy volunteers. In all study periods the volunteers receive a single oral 600 mg dose of test medicine, as either the reference Capsule or one of three prototype capsules. For each period, volunteers enter the clinical unit on Day -1 (the day before dosing) and are discharged on Day 4 (72 hours post dose). There is a minimum washout period of 10 days between each administration of study drug. There is also a follow up phone call 7 to 10 days following the final dose. Volunteer’s blood and urine samples are collected throughout the study for analysis of the test medicine and for their safety. Volunteers are expected to be involved in this study for about up to approximately 10 weeks, from screening to the follow-up visit.\n \nWhat are the potential benefits and risks of participating?\nParticipants get no medical benefit from taking part in this study. However, development of a cancer treatment for children may benefit the paediatric population as a whole. It is considered that the risk/benefit evaluation in this study supports the use of healthy volunteers. Full information on possible side effects is provided to volunteers in the Participant Information Sheet/Informed Consent Form. Volunteers are closely monitored during the study and safety assessments are performed regularly.\n
REC name
HSC REC B
REC reference
21/NI/0177
Date of REC Opinion
1 Dec 2021
REC opinion
Further Information Favourable Opinion