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

NCT05817461 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-06-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

AZD0780 tablet

oral, fasted

DRUG

[14C]AZD0780 Solution for Infusion

intravenous

DRUG

[14C]AZD0780 Oral Solution

oral, fasted

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Somasekhara Menakuru, MBBS, MS, MRCS, DPM, MFPM · Quotient Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2023-06-06
Completion
2023-06-06

Countries

  • United Kingdom

Study Locations

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Diseases
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 NCT05817461 on ClinicalTrials.gov