Mass Balance Recovery, PK and Metabolite Profile & ID of [14C]AZD7594
Research type
Research Study
Full title
A Phase I, Open-Label Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification after Intravenous Administration of [14C]AZD7594 and Inhaled Administration of AZD7594 in Healthy Subjects
IRAS ID
261135
Contact name
Maria Nieto-Gutierrez
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-000675-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 10 days
Research summary
The Sponsor is developing the test medicine, AZD7594, for the potential treatment of asthma.
The study will try to identify the amount of radioactivity found in the blood, urine and faeces following a single radiolabelled dose AZD7594 ([14C]AZD7594) given by slow infusion into the vein. 'Radiolabelled’ means that the test medicine has a radioactive component which helps us to track where the test medicine and it's breakdown products (it’s metabolites) are ie in the blood, urine and/or faeces. The breakdown products of AZD7594 (the metabolite profile) and their chemical structure will also be investigated. The study will also investigate how much of the test medicine is taken up by the body when inhaled.
The study will involve 6 healthy male or non-pregnant, non-lactating healthy female volunteers. Each volunteer will receive a single inhaled nominal dose of 792 μg (720 μg delivered dose) of AZD7594 followed by a single intravenous dose of 30 μg radiolabelled AZD7594, as a slow injection into the vein (infusion over 1 hour).
Blood, urine and faecal samples will then be collected at regular intervals from each volunteer who will be resident in the clinical unit for 8 days (168 hours).
REC name
Wales REC 2
REC reference
19/WA/0116
Date of REC Opinion
11 Apr 2019
REC opinion
Favourable Opinion