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A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects

NCT05384262 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2024-07-19

No results posted yet for this study

Summary

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels.

This study will consist of two parts (Parts A and B).

56 subjects have been planned for Part A and 141 subjects for Part B. Additional subjects may be included for the optional cohorts depending upon emerging data.

Conditions

Interventions

DRUG

AZD0780

Subjects will receive AZD0780 orally as a single ascending dose.

DRUG

AZD0780

Subjects will receive AZD0780 orally as a multiple ascending dose.

DRUG

AZD0780

Subjects will receive AZD0780 orally as a single and multiple ascending dose.

DRUG

Placebo

Subjects will receive placebo matching the AZD0780 dose orally as a single ascending dose.

DRUG

Placebo

Subjects will receive placebo matching the AZD0780 dose orally as a multiple ascending dose.

DRUG

Placebo

Subjects will receive placebo matching the AZD0780 dose orally as a single and multiple ascending dose.

DRUG

Rosuvastatin

Subjects will receive rosuvastatin orally.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2024-06-14
Completion
2024-06-14
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT05384262 on ClinicalTrials.gov