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.

Sponsor
AstraZeneca
Study ID
NCT05662033
Phase
PHASE1
Status
Completed

Conditions

  • Inflammatory Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • AZD6793 — DRUG
    AZD6793 will be administered orally
  • Placebo — DRUG
    Placebo will be administered orally

Study Details

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.

Key Dates

Start date
Dec 5, 2022
Status verified
Oct 2025
Primary completion
Oct 29, 2024
Completion
Oct 29, 2024

Study Design

Enrollment
93 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (SAD): Cohort 1
    6 Healthy participants will receive a single oral dose A of AZD6793 and 2 healthy participants will receive placebo
  • Experimental: Part 1 (SAD): Cohort 2
    6 Healthy participants will receive a single oral dose B of AZD6793 and 2 healthy participants will receive placebo
  • Experimental: Part 1 (SAD): Cohort 3
    6 Healthy participants will receive a single oral dose C of AZD6793 and 2 healthy participants will receive placebo
  • Experimental: Part 1 (SAD): Cohort 4
    6 Healthy participants will receive a single oral dose D of AZD6793 and 2 healthy participants will receive placebo
  • Experimental: Part 1 (SAD): Cohort 5
    6 Healthy participants will receive a single oral dose E of AZD6793 and 2 healthy participants will receive placebo
  • Experimental: Part 2 (MAD): Cohort 1
    6 Healthy participants will receive dose W of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7
  • Experimental: Part 2 (MAD): Cohort 2
    6 Healthy participants will receive dose X of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7
  • Experimental: Part 2 (MAD): Cohort 3
    6 Healthy participants will receive dose Y of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7
  • Experimental: Part 2 (MAD) : Cohort 4
    6 Healthy participants will receive dose Z of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7
  • Experimental: Part 3: Treatment sequence 1
    Participants will receive a single oral dose of test formulation AZD6793 in fasted state, test formulation AZD6793 in fed state following reference formulation AZD6793 in fasted state once on Day 1 of each treatment period.
  • Experimental: Part 3: Treatment sequence 2
    Participants will receive a single oral dose of test formulation AZD6793 in fed state, reference formulation AZD6793 in fasted state following test formulation AZD6793 in fasted state once on Day 1 of each treatment period.
  • Experimental: Part 3: Treatment sequence 3
    Participants will receive a single oral dose of reference formulation AZD6793 in fasted state, test formulation AZD6793 in fasted state following test formulation AZD6793 in fed state once on Day 1 of each treatment period.
  • Experimental: Part 4 (COPD): Cohort 1
    10 participants with COPD will receive AZD6793 once daily and 5 participants with COPD will receive placebo

Primary Outcome Measure

Part 1 (SAD): Number of participants with adverse events [ Time Frame: From screening up to Follow up visit (Day 6±1) ]

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