An ADME Study of [14C]AZD0780 in Healthy Male Subjects

Sponsor
AstraZeneca
Study ID
NCT05817461
Phase
PHASE1
Status
Completed

Conditions

  • Cardiovascular Diseases

Eligibility Criteria

Sex
MALE
Age
30 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The Sponsor is developing a new test medicine, AZD0780, with the aim to lower low-density lipoprotein cholesterol (LDL-C, fatty deposits) levels and cardiovascular (heart disease) risk, when given on top of standard care. This two-part healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14; also referred as 14C) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied. This study will take place at one non-NHS site, enrolling up to 8 male volunteers aged between 30 and 55 years.

Key Dates

Start date
Apr 19, 2023
Status verified
Jun 2025
Primary completion
Jun 6, 2023
Completion
Jun 6, 2023

Study Design

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

Arms

  • Experimental: AZD0780
    In Part 1, one oral dose of AZD0780 and one intravenous dose of \[14C\]AZD0780. In Part 2, one oral dose of \[14C\]AZD0780

Primary Outcome Measure

Absolute bioavailability (F) - Part 1 [ Time Frame: Plasma sample collection from pre-dose to 168 hours post-dose ]

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