Study to explore different formulations of entrectinib (QSC201525)
Research type
Research Study
Full title
A RANDOMIZED, OPEN-LABEL, TWO PART STUDY TO EXPLORE THE PERFORMANCE OF ENTRECTINIB PROTOTYPE MINI-TABLET FORMULATIONS AND THE EFFECT OF DRUG SUBSTANCE PARTICLE SIZE ON ENTRECTINIB BIOAVAILABILITY IN HEALTHY VOLUNTEERS
IRAS ID
263302
Contact name
Eric Olson
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2019-000783-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
The Sponsor is developing a new test medicine, Entrectinib, for the potential treatment of a variety of tumour types, including non-small cell lung cancer (a type of lung cancer), colorectal carcinoma (cancer of the lower bowel), salivary gland cancers, papillary thyroid cancer (a type of cancer that affects the thyroid gland), melanoma (a type of cancer that develops from the pigment-containing cells which typically occur in the skin) and sarcomas (cancers which affect the bone, cartilage, fat, muscle, blood vessels, or tissues involved in the development of blood cells).
This study will investigate different formulations (recipes) of the test medicine, including formulations suitable for children and for adults who have difficulties with swallowing tablets/capsules (referred to as a ‘paediatric formulation’). The paediatric formulations will be administered orally (via the mouth) mixed with yoghurt (Part 1 only).
The study will consist of 2 parts. In Part 1, 15 healthy male volunteers and healthy female volunteers of non-child bearing potential (WONCBP) will attend the clinical unit on 3 occasions (periods) to receive oral doses of 2 paediatric tablet formulations (recipes) and 1 reference capsule formulation of entrectinib under fed conditions. In Part 2, 16 healthy male volunteers and healthy female volunteers of non-child bearing potential (WONCBP) will attend the clinical unit on 2 occasions to receive oral doses of 2 capsule formulations of entrectinib under fasting conditions.
In both Parts, volunteers will remain in the clinic until Day 3 and attend return visits on Days 4 and 5. Volunteers will receive a follow-up call 13 to 15 days after their final dose to ensure their continued wellbeing.
REC name
HSC REC A
REC reference
19/NI/0082
Date of REC Opinion
7 May 2019
REC opinion
Favourable Opinion