CompletedPhase 1

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.

United Kingdom93 participantsStarted 2022-12-05

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Non-childbearing potential confirmed at screening
✓. If considered of childbearing potential, must agree to use with their partner an approved method of highly effective contraception.

What they're measuring

Part 1 (SAD): Number of participants with adverse events

Timeframe: From screening up to Follow up visit (Day 6±1)

Part 2 (MAD): Number of participants with adverse events

Timeframe: From screening up to Follow up visit (Day 14±1)

Part 1 (SAD): Number of participants with abnormal findings in vital signs (supine Blood Pressure (BP), pulse, respiratory rate, peripheral oxygen saturation (SpO2) and oral body temperature)

Timeframe: From screening, Treatment Day 1 to Day 4 up to Follow up visit (Day 6±1)

Part 2 (MAD): Number of participants with abnormal findings in vital signs (supine Blood Pressure (BP), pulse, respiratory rate, peripheral oxygen saturation (SpO2) and oral body temperature)

Timeframe: From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1)

Part 1 (SAD): Number of participants with abnormal findings in 12 Lead electrocardiogram (ECG)

Timeframe: From screening, Treatment Day -1 to Day 4 up to Follow up visit (Day 6±1)

Part 2 (MAD): Number of participants with abnormal findings in 12 Lead electrocardiogram (ECG)

Timeframe: From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1)

Trial details

NCT IDNCT05662033

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-29

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