Relative bioavailability of Alectinib Tablet (QSC300271/JP44468)

  • Research type

    Research Study

  • Full title

    A Two-Part, Two-Way Crossover, Randomised, Open-Label Study Designed to Evaluate the Relative Bioavailability of a Novel Oral Alectinib Tablet Formulation Compared with Oral Reference Alectinib Capsule, in the Fed and Fasted State in Healthy Subjects

  • IRAS ID

    1006569

  • Contact name

    Miki Nomura

  • Contact email

    JP44468@mail.chugai-pharm.co.jp

  • Sponsor organisation

    Chugai Pharmaceutical Co. Ltd

  • ISRCTN Number

    ISRCTN40852430

  • Research summary

    Background and study aims\nThe Sponsor is developing a new oral formulation of the test medicine, alectinib, for the treatment of certain types of cancer, namely metastatic (cancer that has spread in the body from where it started) non-small cell lung cancer. The aim of this healthy volunteer study is to compare a new tablet formulation of the test medicine against the approved existing capsule formulation. This study is comparing how the two different formulations of the test medicine are taken up by the body (the pharmacokinetics) in the fed and fasted (empty stomach) states. The study is also looking at the safety and tolerability of 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 two parts, each consisting of two study periods, involving up to 32 healthy volunteers. In Part 1 of the study the volunteers receive a single oral 600 mg dose of test medicine, as either the reference capsule or tablet in the fed state on two separate occasions. In Part 2 of the study the volunteers receive a single oral 600 mg dose of test medicine, as either the reference capsule or tablet in the fasted state on two separate occasions. 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 visit 7 to 10 days following the final dose. Volunteer’s blood samples are collected throughout the study for analysis of the test medicine and for their safety alongside urine samples for their safety. Volunteers are expected to be involved in this study for up to approximately 8 weeks, from screening to the follow-up visit.\n\nWhat are the possible risks and benefits of participating?\nParticipants get no medical benefit from taking part in this study. However, development of a treatment for cancer may benefit the 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

    London - Surrey Borders Research Ethics Committee

  • REC reference

    22/LO/0834

  • Date of REC Opinion

    11 Jan 2023

  • REC opinion

    Further Information Favourable Opinion