Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD6793 · 4 trials · 3 indications
The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo
The effect of itraconazole on the single-dose Cmax of AZD6793 will be evaluated in healthy participants.
The effect of itraconazole on the single-dose AUClast of AZD6793 will be evaluated in healthy participants.
The effect of itraconazole on the single-dose AUCinf of AZD6793 will be evaluated in healthy participants.
The effect of itraconazole on the single-dose CL/F of AZD6793 will be evaluated in healthy participants.
The effect of itraconazole on the single-dose t1/2λz of AZD6793 will be evaluated in healthy participants.
The effect of itraconazole on the single-dose tmax of AZD6793 will be evaluated in healthy participants.
The effect of itraconazole on the single-dose Vz/F of AZD6793 will be evaluated in healthy participants.
The effect of itraconazole on the single-dose RAUCinf of AZD6793 will be evaluated in healthy participants.
The effect of itraconazole on the single-dose RAUClast of AZD6793 will be evaluated in healthy participants.
The effect of itraconazole on the single-dose RCmax of AZD6793 will be evaluated in healthy participants.
To assess the safety and tolerability of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants.
To assess the safety and tolerability of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Evaluating the relative oral bioavailability between the test formulation and the reference formulation after a single oral dose of AZD6793 in healthy participants.
Evaluating the relative oral bioavailability between the test formulation and the reference formulation after a single oral dose of AZD6793 in healthy participants.
Investigating the effect of a high fat high calorie (HFHC) meal compared to fasting conditions, on the PK of AZD6793 after a single oral dose in healthy participants.
Investigating the effect of a high fat high calorie (HFHC) meal compared to fasting conditions, on the PK of AZD6793 after a single oral dose in healthy participants.
Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.
Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.
Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.
Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.
Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.
| Arm | Type | Description |
|---|---|---|
| Dose 1 of AZD6793 | EXPERIMENTAL | Approximately 290 participants will be randomized to receive Dose 1 of AZD6793 |
| Dose 2 of AZD6793 | EXPERIMENTAL | Approximately 290 participants will be randomized to receive Dose 2 of AZD6793 |
| Matching Placebo | PLACEBO_COMPARATOR | Approximately 290 participants will be randomized to receive Matching Placebo |
| AZD6793 and Itraconazole | EXPERIMENTAL | Participants will receive a single dose of AZD6793 on Day 1. On Day 4, the participant will receive 2 doses of 200 mg itraconazole 12 hours apart followed by a single dose of 200 mg itraconazole from Days 5 to 7. On Day 8, participants will receive a combined dose of AZD6793 and 200 mg itraconazole. On Day 9 and Day 10, the participants will receive a single dose of 200 mg itraconazole. |
| Part 1: Cohort 1 AZD6793 | EXPERIMENTAL | 6 Healthy Japanese participants will receive single dose of AZD6793 dose 1 and 2 healthy Japanese participants will receive matching placebo to AZD6793 as oral suspension on Day 1. |
| Part 1: Cohort 2 AZD6793 | EXPERIMENTAL | 6 Healthy Japanese participants will receive single dose of AZD6793 dose 2 and 2 healthy Japanese participants will receive matching placebo to AZD6793 as oral suspension on Day 1. |
| Part 1: Cohort 3 AZD6793 | EXPERIMENTAL | 6 Healthy Chinese participants will receive single dose of AZD6793 dose 1 and 2 healthy Chinese participants will receive matching placebo to AZD6793 as oral suspension on Day 1. |
| Part 2: Cohort 1 AZD6793 | EXPERIMENTAL | 6 Japanese participants will receive single dose of AZD6793 and 2 participants will receive matching placebo on Day 1. After a washout of at least 48 hours, participants will receive AZD6793 or placebo once daily from Day 3 to Day 8. |
| Part 2: Cohort 2 AZD6793 | EXPERIMENTAL | 6 Chinese participants will receive single dose of AZD6793 and 2 participants will receive matching placebo on Day 1. After a washout of at least 48 hours, participants will receive AZD6793 or placebo once daily from Day 3 to Day 8. |
| Part 1 (SAD): Cohort 1 | EXPERIMENTAL | 6 Healthy participants will receive a single oral dose A of AZD6793 and 2 healthy participants will receive placebo |
| Part 1 (SAD): Cohort 2 | EXPERIMENTAL | 6 Healthy participants will receive a single oral dose B of AZD6793 and 2 healthy participants will receive placebo |
| Part 1 (SAD): Cohort 3 | EXPERIMENTAL | 6 Healthy participants will receive a single oral dose C of AZD6793 and 2 healthy participants will receive placebo |
| Part 1 (SAD): Cohort 4 | EXPERIMENTAL | 6 Healthy participants will receive a single oral dose D of AZD6793 and 2 healthy participants will receive placebo |
| Part 1 (SAD): Cohort 5 | EXPERIMENTAL | 6 Healthy participants will receive a single oral dose E of AZD6793 and 2 healthy participants will receive placebo |
| Part 2 (MAD): Cohort 1 | EXPERIMENTAL | 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 |
| Part 2 (MAD): Cohort 2 | EXPERIMENTAL | 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 |
| Part 2 (MAD): Cohort 3 | EXPERIMENTAL | 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 |
| Part 2 (MAD) : Cohort 4 | EXPERIMENTAL | 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 |
| Part 3: Treatment sequence 1 | EXPERIMENTAL | 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. |
| Part 3: Treatment sequence 2 | EXPERIMENTAL | 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. |
| Part 3: Treatment sequence 3 | EXPERIMENTAL | 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. |
| Part 4 (COPD): Cohort 1 | EXPERIMENTAL | 10 participants with COPD will receive AZD6793 once daily and 5 participants with COPD will receive placebo |
| Name | Type | Description |
|---|---|---|
| AZD6793 | DRUG | Oral dosage |
| Placebo | OTHER | Oral dosage |
| Itraconazole | DRUG | Participants will receive 2 doses of itraconazole on Day 4 and single dose from Day 5 to Day 7 in Period 2. On Day 8 participants will receive single dose of itraconazole combined with AZD6793 and then single dose of itraconazole from Day 9 to Day 10 in Period 3. |
| AZD6793+ Itraconazole | DRUG | Participants will receive a combined dose of AZD6793 and itraconazole on Day 8 in Period 3. |
Inclusion Criteria: * Participant must be ≥40 years of age at the time of signing the informed consent. * Documented primary diagnosis of COPD for at least 12 months prior to enrolment. * Pre-BD FEV1/FVC \< 0.7 at Visit 1 and pre- and post-BD FEV1/FVC \< 0.7, and post-BD FEV1 ≥ 25% to \< 80% of pre...
AZD6793 is an investigational small molecule being developed for respiratory and inflammatory diseases. It is currently being studied in a Phase 2 clinical trial for the treatment of moderate to very severe chronic obstructive pulmonary disease (COPD). The drug is administered orally and is being evaluated in patients aged 40 years and older.
AZD6793 is being developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca's stock is traded under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of AZD6793 in healthy participants and in patients with chronic obstructive pulmonary disease.
AZD6793 is currently in Phase 2 clinical development. A Phase 2 trial (NCT07082738) is recruiting participants with moderate to very severe chronic obstructive pulmonary disease. This follows the completion of several Phase 1 studies that assessed the drug's safety, tolerability, and pharmacokinetics in healthy participants. AZD6793 is not yet approved by regulatory authorities.
AZD6793 is being evaluated in a Phase 2 trial (NCT07082738) for chronic obstructive pulmonary disease, which is currently recruiting. Additionally, three Phase 1 trials have been completed: NCT05662033, NCT06368440, and NCT06494644, which studied the drug in healthy participants and in participants with inflammatory diseases.
AZD6793 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for chronic obstructive pulmonary disease. The drug has completed Phase 1 trials that evaluated its safety and pharmacokinetics in healthy participants. Approval from regulatory authorities would require successful completion of further clinical trials and a formal review process.