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A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833

NCT04546347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-01-20

No results posted yet for this study

Summary

AstraZeneca AB is developing the test medicine, AZD9833, for the potential treatment of oestrogen receptor (ER) positive breast cancer. ER-positive breast cancer is where the cancer cells grow in response to the hormone oestrogen.

The study will try to identify and compare how much of the test medicine formulations (recipes) are taken up into the blood when given as a tablet, a solution and as an injection directly into the vein. The dose given directly into the vein will be radiolabelled, meaning that it contains a radioactive component in order to track where the drug is in the body.

This study will also look at the effect of food when taking the test medicine in the form of the tablet. The test medicine safety and tolerability will also be assessed.

This is a one-part study involving up to 32 healthy post-menopausal female volunteers aged 50 to 70. Volunteers will be randomly assigned to a group of up to 8, two groups will partake in four study periods and two groups will partake in three study periods. Volunteers will be admitted to the clinical unit on the day before dosing (Day -1) for each study period. On Day 1 of each study period, volunteers will receive either a single oral dose (tablet or solution) of AZD9833 or a single oral dose (tablet) of AZD9833 co-administered with a single radiolabelled IV dose of \[14C\]AZD9833, in either the fed or fasted state. There will be a minimum 7 day washout between periods.

Volunteers will remain resident until 72 hours post dose (Day 4) of each study period. A follow-up phone call will take place 5 to 7 days post-final dose to ensure the ongoing wellbeing of the volunteers.

Conditions

  • Healthy Volunteers

Interventions

RADIATION

[14C]AZD9833 Solution for Infusion, (NMT 22.8 kBq/5mL)

Dose of \[14C\]AZD9833 Solution for Infusion

DRUG

AZD9833 film-coated tablet A Dose 1

Dose 1 AZD9833 film-coated tablet A Dose 1

DRUG

AZD9833 Oral Solution

AZD9833 Oral Solution

DRUG

AZD9833 film-coated tablet B Dose 1

AZD9833 film-coated tablet B Dose 1

DRUG

AZD9833 film-coated tablet A Dose 2

Dose 1 of AZD9833 film-coated tablet A Dose 2

DRUG

AZD9833 film-coated tablet B Dose 2

Dose 1 of film-coated tablet B Dose 2

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Somasekhara Menakuru, MBBS MS MRCS · Quotient Sciences Limited (indemnified by Medical Protection Society)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2021-01-07
Completion
2021-01-07

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546347 on ClinicalTrials.gov