* Relative bioavailability study of Alectinib (QSC204446/JP43290)
Research type
Research Study
Full title
Single Part, Open-Label, Phase 1 Study Designed to Evaluate the Relative Bioavailability of Oral Alectinib Formulations Compared with an Oral Reference Alectinib Capsule, in Healthy Subjects
IRAS ID
301567
Contact name
Morihiko Hayashi
Contact email
Sponsor organisation
Chugai Pharmaceutical Co., Ltd.
Eudract number
2021-003298-78
ISRCTN Number
ISRCTN12868063
Duration of Study in the UK
0 years, 3 months, 9 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 taste (palatability) 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 6 study periods involving up to 26 healthy volunteers. In all study periods, the volunteers receive a single oral 600 mg dose of test medicine, as either the reference capsule, powder for oral suspension, oral powder or minitablet. 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. Following both Period 3 and Period 5 there will be a minimum 14 day period to allow the data to be analysed. 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 41 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.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0182
Date of REC Opinion
23 Aug 2021
REC opinion
Further Information Favourable Opinion