Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male Subjects

Sponsor
AstraZeneca
Study ID
NCT04675021
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
MALE
Age
30 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The Sponsor is developing the test medicine, AZD6094 (Savolitinib) for the potential treatment of cancer. Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably, causing a growth called a tumour. The test medicine works to inhibit a pathway within the body which promotes tumours to grow and spread. The study involves radiolabelling (labelling the molecule with radioactive 14C) which is used to locate the molecule within the body. The study will evaluate the absolute bioavailability of the test medicine (amount of the oral test medicine that enters the blood stream relative to the dose given into the vein), along with the mass balance (how much radioactivity can be recovered from the urine and faeces) and the rates and routes of elimination of \[14C\]savolitinib. It will also look to identify the breakdown products (metabolites) of the test medicine. The safety and tolerability of the test medicine will be assessed. The study will consist of two parts, involving a minimum of eight healthy male volunteers. In Part one, following a high fat breakfast, volunteers will receive a single oral dose of the test medicine, followed by an intravenous infusion (solution into the vein) of radiolabelled test medicine. Volunteers will remain resident in the clinical unit until 72 hours post-oral dose. There will then be a washout period of at least 14 days, after which the volunteers will return to the clinical unit for Part two. Volunteers will receive a single oral dose of radiolabelled test medicine as an oral solution. Blood, urine and faecal samples will be collected from volunteers whilst they are resident in the clinical unit for up to 168 hours postdose (Day 8). Volunteers will return for a follow-up visit at least 14 days after their last dose for safety assessments.

Key Dates

Start date
Nov 13, 2020
Status verified
Jan 2021
Primary completion
Jan 11, 2021
Completion
Jan 11, 2021

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AZD6094 (Savolitinib) D5084C00010
    All volunteers will receive either a single dose or two doses of AZD6094 (Savolitinib) D5084C00010

Primary Outcome Measure

Absolute Bioavailability (F) of savolitinib [ Time Frame: Collection of plasma samples from pre-dose to 72 hours post-dose ]

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