Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT05662033
Status:
COMPLETED
Last Update Posted:
2025-10-29
First Post:
2022-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
Official Title:
A Blinded, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an Oral Suspension of AZD6793 Following Single and Multiple Ascending Doses in Healthy Subjects, an Open-label Study to Assess the Relative Bioavailability and Food Effect of a Tablet Formulation of AZD6793 in Healthy Subjects and a Blinded, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Tablet Formulation of AZD6793 in Patients With Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Parts 1, 2, and 3 were conducted in a single center and Part 4 is conducted in 2 centers.
Part 1 of the study will comprise:
* A Screening Period of maximum 28 days (Day -29 to Day -2)
* A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 (the day before IMP administration \[Day 1\]) until at least 72 hours after IMP administration. Participants will then be discharged on Day 4 if in good health and after all samples have been collected. Depending on the emerging data, the length of the stay at the Clinical Unit may be changed.
* A Follow-up Visit within 6 ± 1 days after the IMP dose (this visit may be done later if indicated, for example, if emerging PK data indicates a longer AZD6793 half-life than was predicted).
Part 2 of the study will comprise:
* A Screening Period of maximum 28 days (Day -29 to Day -2).
* A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 (the day before first IMP administration \[Day 1\]) until Day 10. participants will receive a single dose of IMP in the morning on Day 1. After a washout of at least 48 hours (depending on PK data from Part 1), participants will be dosed twice daily (12 hours apart) from Day 3 through Day 7. Participants will receive the last dose of IMP in the morning of Day 8. Participants will then be discharged on Day 10 if in good health and after all samples have been collected.
* A Follow-up Visit within 6 ± 1 days after the last IMP dose (this visit may be done later if indicated, for example, if emerging PK data indicates a longer AZD6793 half-life than was predicted).
Part 3 of the study will comprise:
* A Screening Period of maximum 28 days (Day -29 to Day -2).
* A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 until Day 3. Participants will be randomised on Day 1 of Visit 3 to one of 3 treatment sequences and will receive AZD6793 on Day 1 of each treatment period. Dose administration will be separated by a washout period of at least 3 days from the previous IMP dose of each treatment period.
* A Follow-up Visit within 6 ± 1 days after the last IMP dose
Part 4 of the study will comprise:
* A Screening Period of maximum 35 days (Day -35 to -2)
* A Treatment Period of up to 28 days (at least 26 days) of dosing with AZD6793 or placebo. The participants will be admitted to the Clinical Unit on Day -1 and will receive single dose of AZD6793 or placebo on Day 1 and discharged from the Clinical Unit in the evening on Day 1 (12 hours post-dose).
* A Follow--up Visit 6 ± 2 days after the last IMP dose
Part 1 of the study will comprise:
* A Screening Period of maximum 28 days (Day -29 to Day -2)
* A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 (the day before IMP administration \[Day 1\]) until at least 72 hours after IMP administration. Participants will then be discharged on Day 4 if in good health and after all samples have been collected. Depending on the emerging data, the length of the stay at the Clinical Unit may be changed.
* A Follow-up Visit within 6 ± 1 days after the IMP dose (this visit may be done later if indicated, for example, if emerging PK data indicates a longer AZD6793 half-life than was predicted).
Part 2 of the study will comprise:
* A Screening Period of maximum 28 days (Day -29 to Day -2).
* A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 (the day before first IMP administration \[Day 1\]) until Day 10. participants will receive a single dose of IMP in the morning on Day 1. After a washout of at least 48 hours (depending on PK data from Part 1), participants will be dosed twice daily (12 hours apart) from Day 3 through Day 7. Participants will receive the last dose of IMP in the morning of Day 8. Participants will then be discharged on Day 10 if in good health and after all samples have been collected.
* A Follow-up Visit within 6 ± 1 days after the last IMP dose (this visit may be done later if indicated, for example, if emerging PK data indicates a longer AZD6793 half-life than was predicted).
Part 3 of the study will comprise:
* A Screening Period of maximum 28 days (Day -29 to Day -2).
* A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 until Day 3. Participants will be randomised on Day 1 of Visit 3 to one of 3 treatment sequences and will receive AZD6793 on Day 1 of each treatment period. Dose administration will be separated by a washout period of at least 3 days from the previous IMP dose of each treatment period.
* A Follow-up Visit within 6 ± 1 days after the last IMP dose
Part 4 of the study will comprise:
* A Screening Period of maximum 35 days (Day -35 to -2)
* A Treatment Period of up to 28 days (at least 26 days) of dosing with AZD6793 or placebo. The participants will be admitted to the Clinical Unit on Day -1 and will receive single dose of AZD6793 or placebo on Day 1 and discharged from the Clinical Unit in the evening on Day 1 (12 hours post-dose).
* A Follow--up Visit 6 ± 2 days after the last IMP dose
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-002951-21 | EUDRACT_NUMBER | None | View |