Your session is about to expire
← Back to Search
Other
AZD8965 for Healthy Subjects
Phase 1
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception with low user dependency
Participants must have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 45 kg
Must not have
Known or suspected defect in the function of the urea cycle or family history of a urea cycle disorder
Ongoing acquired or inherited immunodeficiency disorders or taking immune replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up parts 1 and 3a: from day 1 (pre-dose) to day 4 (72-hour post dose); parts 2 and 3b: from day 1 (pre-dose) to day 10 (48-hour post dose)
Summary
This trial aims to test the safety and how well a new drug called AZD8965 is tolerated in healthy individuals. It will also look at how the body processes the drug after single and multiple doses
Who is the study for?
This trial is for healthy individuals, including those of Japanese and Chinese descent. It's designed to test the safety and how the body processes a new drug called AZD8965, both on an empty stomach and with food.
What is being tested?
The study involves giving participants either AZD8965 or a placebo (a substance with no active drug). They'll receive varying doses to see how well they tolerate it and how their bodies handle the drug over time.
What are the potential side effects?
Since this is an early-stage trial for AZD8965 in healthy people, specific side effects are not yet known. The study aims to identify any potential reactions or issues related to taking the medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not breastfeeding and agree to use effective birth control if I'm sexually active.
Select...
My BMI is between 18 and 30, and I weigh at least 45 kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or might have a problem with my urea cycle, or it runs in my family.
Select...
I have an immune deficiency or am on immune therapy.
Select...
I have severe allergies to AZD8965 or similar drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ parts 1 and 3a: from day 1 (pre-dose) to day 4 (72-hour post dose); parts 2 and 3b: from day 1 (pre-dose) to day 10 (48-hour post dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~parts 1 and 3a: from day 1 (pre-dose) to day 4 (72-hour post dose); parts 2 and 3b: from day 1 (pre-dose) to day 10 (48-hour post dose)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 4: Accumulation ratio for AUC (Rac AUC)
Part 4: Accumulation ratio for Cmax (Rac Cmax)
Part 4: Apparent total body clearance (CL/F)
+15 moreSecondary study objectives
Part 4: Number of participants with AEs and SAEs
Parts 1, 2, 3A and 3B: Apparent total body clearance (CL/F)
Parts 1, 2, 3A and 3B: Apparent volume of distribution based on the terminal (Vz/F)
+14 moreTrial Design
14Treatment groups
Experimental Treatment
Group I: Part 4: Food Effect Cohort - AZD8965Experimental Treatment1 Intervention
Participants will receive 2 single dose treatments of AZD8965 \[following an overnight fast of at least 10 hours in a fasted state or a fed state (after a high fat meal)\].
Group II: Part 3B: Single and multiple ascending dose (SMAD) Cohort 1 (Japanese) - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9.
Group III: Part 3B: SMAD Cohort 2 (Chinese) - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9.
Group IV: Part 3A: SAD Cohort 3 (Chinese) - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.
Group V: Part 3A: SAD Cohort 2 (Japanese) - AZD8965 (Dose 2)Experimental Treatment2 Interventions
Japanese participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1.
Group VI: Part 3A: SAD Cohort 1 (Japanese) - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.
Group VII: Part 2: MAD Cohort 3 - AZD8965 (Dose 3)Experimental Treatment2 Interventions
Participants will receive multiple doses of AZD8965 (Dose 3) or matching placebo to AZD8965 from Day 1 to Day 8.
Group VIII: Part 2: MAD Cohort 2 - AZD8965 (Dose 2)Experimental Treatment2 Interventions
Participants will receive multiple doses of AZD8965 (Dose 2) or matching placebo to AZD8965 from Day 1 to Day 8.
Group IX: Part 2: MAD Cohort 1 - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Participants will receive multiple doses of AZD8965 (Dose 1) or matching placebo to AZD8965 from Day 1 to Day 8.
Group X: Part 1: SAD Cohort 5 - AZD8965 (Dose 5)Experimental Treatment2 Interventions
Participants will receive a single dose of AZD8965 (Dose 5) or matching placebo to AZD8965 on Day 1.
Group XI: Part 1: SAD Cohort 4 - AZD8965 (Dose 4)Experimental Treatment2 Interventions
Participants will receive a single dose of AZD8965 (Dose 4) or matching placebo to AZD8965 on Day 1.
Group XII: Part 1: SAD Cohort 3 - AZD8965 (Dose 3)Experimental Treatment2 Interventions
Participants will receive a single dose of AZD8965 (Dose 3) or matching placebo to AZD8965 on Day 1.
Group XIII: Part 1: SAD Cohort 2 - AZD8965 (Dose 2)Experimental Treatment2 Interventions
Participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1.
Group XIV: Part 1: SAD Cohort 1 - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,317 Total Patients Enrolled