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A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy and Chronic Obstructive Pulmonary Disease Participants, to Assess the Relative Oral Bioavailability Between Two Formulations, and the Food Effect on the PK of AZD6793 Compared to Fasting State.

NCT05662033 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2025-10-29

No results posted yet for this study

Summary

The purpose of the study is to assess the safety and tolerability of AZD6793 suspension following oral administration of Single Ascending Dose (SAD) \[Part 1\] and Multiple Ascending Dose (MAD) \[Part 2\] in healthy participants.

Additionally, the study will include Part 3 (bioavailability and food effect cohort) to assess the relative oral bioavailability between test formulation and oral suspension (reference formulation) as well as the effect of a high fat high calorie (HFHC) meal on the PK of AZD6793 test formulation, in comparison to fasting conditions, after a single oral dose of AZD6793 in healthy participants.

Part 4 of the study (Chronic Obstructive Pulmonary Disease \[COPD\] cohort) is intended to evaluate AZD6793 safety, tolerability, and PK profile for the first time in participants with moderate to severe COPD.

Part 1 (SAD), Part 2 (MAD) and Part 3 (Bioavailability and food effect cohort) have been completed. Although it was planned that 5 cohorts would be included in Part 1, only 4 cohorts (32 participants) were included. Part 3 of the study was concluded with 13 healthy participants.

Conditions

Interventions

DRUG

AZD6793

AZD6793 will be administered orally

DRUG

Placebo

Placebo will be administered orally

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2024-10-29
Completion
2024-10-29

Countries

  • 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 NCT05662033 on ClinicalTrials.gov