A study to investigate the safety, tolerability, and pharmacokinetics (PK) of oral AZD6793 in healthy subjects and to assess the relative oral bioavailability between two formulations. The study will also assess the food effect on the PK of AZD6793 compared to fasting state

Study identifier:D7860C00001

ClinicalTrials.gov identifier:NCT05662033

EudraCT identifier:2022-002951-21

CTIS identifier:N/A

Recruiting

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

Medical condition

Inflammatory diseases

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD6793, Placebo

Sex

All

Estimated Enrollment

133

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 05 Dec 2022

Estimated Primary Completion Date: 27 Sept 2024

Estimated Study Completion Date: 27 Sept 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Healthy male or female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture
- Females must have a negative pregnancy test must not be lactating and must be either (a) non-childbearing potential, confirmed by post-menopausal defined as amenorrhea for at least 12 months; documentation of irreversible surgical sterilisation or (b) childbearing potential, i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile (Must agree to use, with their partner, an approved method of highly effective contraception).
- Male subjects and their female partners of childbearing potential must be willing to use highly effective contraception measures and male subjects must refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of IMP.
-Have a BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg, at the Screening Visit.

Exclusion Criteria

- History or presence of gastrointestinal, hepatic, renal, pancreatic disease or acute disease in these organs.
-History of chronic haematologic disease.
-Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection
-Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
-Parts 1 and 2 only: Positive or indeterminate QuantiFERON® Tuberculosis (TB) test at screening.
-Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results
-Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), hepatitis C antibody and Human immunodeficiency virus (HIV).
-Any clinically important abnormalities in rhythm, conduction or morphology of the resting Electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
-Known or suspected history of alcohol and drug abuse in the last year.
-Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the previous 3 months.
-History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD6793.
-Excessive intake of caffeine containing drinks or food
-Use of drugs with enzyme inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP.
-Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life
-Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
-Parts 2 and 3 only: Subjects who have previously received AZD6793.

The study will be conducted at a single study centre and comprises of 3 parts. Parts 1, 2, and 3 will serve as SAD, MAD, bioavailability and food effect, respectively. Part 1 of the study will comprise: •A Screening Period of maximum 28 days (Day -29 to Day -2) •A Treatment Period during which subjects 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. Subjects 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 subjects will be resident at the Clinical Unit from Day -1 (the day before first IMP administration [Day 1]) until Day 10. Subjects 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), subjects will be dosed twice daily (12 hours apart) from Day 3 through Day 7. Subjects will receive the last dose of IMP in the morning of Day 8. Subjects 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 subjects will be resident at the Clinical Unit from Day -1 until Day 3. Subjects 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

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Arms	Assigned Interventions
Experimental: Part 1 (SAD): Cohort 1 6 Healthy subjects will receive a single oral dose A of AZD6793 and 2 healthy subjects will receive placebo	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 1 (SAD): Cohort 2 6 Healthy subjects will receive a single oral dose B of AZD6793 and 2 healthy subjects will receive placebo	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 1 (SAD): Cohort 3 6 Healthy subjects will receive a single oral dose C of AZD6793 and 2 healthy subjects will receive placebo	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 1 (SAD): Cohort 4 6 Healthy subjects will receive a single oral dose D of AZD6793 and 2 healthy subjects will receive placebo	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 1 (SAD): Cohort 5 6 Healthy subjects will receive a single oral dose E of AZD6793 and 2 healthy subjects will receive placebo	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 2 (MAD): Cohort 1 6 Healthy subjects will receive dose W of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 2 (MAD): Cohort 2 6 Healthy subjects will receive dose X of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 2 (MAD): Cohort 3 6 Healthy subjects will receive dose Y of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 2 (MAD) : Cohort 4 6 Healthy subjects will receive dose Z of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 3: Treatment sequence 1 Subjects 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.	Drug: AZD6793 AZD6793 will be administered orally
Experimental: Part 3: Treatment sequence 2 Subjects 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.	Drug: AZD6793 AZD6793 will be administered orally
Experimental: Part 3: Treatment sequence 3 Subjects 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.	Drug: AZD6793 AZD6793 will be administered orally

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]