An ADME Study of [14C]AZD0780 in Healthy Male Subjects
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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. High levels of LDL-C can build up on the walls of
      blood vessels, forming plaques which can increase the risk of heart disease and stroke.

      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.

      In Part 1, volunteers will receive a single oral dose of AZD0780 on Day 1. The volunteers
      will then receive a single intravenous dose of [14C]AZD0780, 2.25 hours after the oral dose.
      Volunteers will be discharged on Day 8. Following a minimum 14 day washout period, all
      volunteers who participated in Part 1 of the study will be admitted to the clinical unit for
      Part 2. In Part 2, the volunteers will receive a single oral dose of [14C]AZD0780 on Day 1.
      Volunteers will be discharged on Day 11, however, if relevant radioactivity criteria have not
      been met, volunteers may need to remain at the clinical unit until Day 13. If relevant
      criteria have not been met at this point, home collections of urine and/or faeces may be
      required.

      Volunteers will receive a follow up phone call between Day 18 and 21.

      Volunteer's blood and urine and faeces will be taken throughout the study for analysis of the
      test medicine and for their safety.

      Volunteers are expected to be involved in this study for 10 weeks from screening to the
      follow up call.
    

Intervention name(s): AZD0780 tablet; [14C]AZD0780 Solution for Infusion; [14C]AZD0780 Oral Solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral, fasted; intravenous; oral, fasted
Other intervention name(s): AZD0780; [14C]AZD0780; [14C]AZD0780
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dyslipidaemia