A single and multiple ascending dose study to investigate the safety, tolerability, and pharmacokinetics of AZD8965 in healthy participants (including Japanese and Chinese participants) and an open-label cohort to assess the effect of food on the pharmacokinetics of AZD8965 in healthy participants

Study identifier:D6960C00001

ClinicalTrials.gov identifier:NCT06502379

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD8965 Following Single and Multiple Ascending Dose Administration to Healthy Participants (including Japanese and Chinese Participants) and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD8965

Sex

All

Estimated Enrollment

163

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 02 Aug 2024

Estimated Primary Completion Date: 17 Oct 2025

Estimated Study Completion Date: 17 Oct 2025

Study design

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

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

• Healthy male and female participants (including Japanese and Chinese participants) with suitable veins for cannulation or repeated venipuncture.
• All females of childbearing potential must have a negative pregnancy test at the Screening Visit (serum) and on admission (urine) to the Clinical Unit.
• 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 and their non-sterilized male partners must use a condom, to avoid pregnancy from the time of first administration of study intervention until 20 days after the last dose of study intervention. Females must not use hormonal contraceptives or hormone replacement therapy during the study.
• Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:
(a) Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and without an alternative medical cause and the follicle stimulating hormone (FSH) level is in the postmenopausal range.
(b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not acceptable.
• Sexually active fertile male participants with partners of childbearing potential must adhere to the specified contraception methods from the time of first administration of study intervention administration until 20 days after the last dose of study intervention.
• Have a body mass index (BMI) between 18 and 30 kilogram (kg)/square meter (m2) inclusive and weigh at least 45 kg.
Part 3A and Part 3B (Japanese Participants)
• Healthy Japanese participants are eligible based on meeting all of the following:
(a) Born in Japan
(b) Have 2 Japanese biological parents and 4 Japanese grandparents.
(c) Did not live outside Japan for more than 10 years at the time of Screening.
Part 3A and Part 3B (Chinese Participants)
• Healthy Chinese participants. Participants of Chinese ancestry are eligible based on meeting all of the following:
(a) Born in mainland China, Hong Kong, Macau, or Taiwan
(b) Have 2 Chinese biological parents and 4 Chinese grandparents as confirmed by the interview.
(c) Did not live outside China for more than 10 years at the time of Screening.

Exclusion Criteria

• History of any clinically important disease or disorder which may either put the participant at risk or influence the results or the participant’s ability to participate in the study.
• Chronic or ongoing gastrointestinal, respiratory, hepatic, renal disease, pancreatic disease, diabetes mellitus, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Chronic or ongoing neurological disorder, any clinically important past or ongoing psychiatric disorder which may confound assessment of the potential neurologic effects of this product.
• Participants with a history of hypertension or cardiovascular disease.
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
• Participant with chronic infections (e.g., urinary tract infection) or who are at increased risk of infection (e.g., surgery, trauma, severe dental disease, or significant infection).
• Participants with a known or suspected defect in the function of the urea cycle, or with family history of a urea cycle disorder in one or more biological relative.
• Any abnormal laboratory values and vital signs.
• Ongoing acquired or inherited immunodeficiency disorders, including but not limited to human immunodeficiency virus (HIV) or common variable immunodeficiency, or the participant is taking immune replacement therapy.
• 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 AZD8965.

Sort by status

No locations available

Arms	Assigned Interventions
Experimental: Part 1: SAD Cohort 1 - AZD8965 (Dose 1) Participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 1: SAD Cohort 2 - AZD8965 (Dose 2) Participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 1: SAD Cohort 3 - AZD8965 (Dose 3) Participants will receive a single dose of AZD8965 (Dose 3) or matching placebo to AZD8965 on Day 1.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 1: SAD Cohort 4 - AZD8965 (Dose 4) Participants will receive a single dose of AZD8965 (Dose 4) or matching placebo to AZD8965 on Day 1.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 1: SAD Cohort 5 - AZD8965 (Dose 5) Participants will receive a single dose of AZD8965 (Dose 5) or matching placebo to AZD8965 on Day 1.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 2: MAD Cohort 1 - AZD8965 (Dose 1) Participants will receive multiple doses of AZD8965 (Dose 1) or matching placebo to AZD8965 from Day 1 to Day 8.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 2: MAD Cohort 2 - AZD8965 (Dose 2) Participants will receive multiple doses of AZD8965 (Dose 2) or matching placebo to AZD8965 from Day 1 to Day 8.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 2: MAD Cohort 3 - AZD8965 (Dose 3) Participants will receive multiple doses of AZD8965 (Dose 3) or matching placebo to AZD8965 from Day 1 to Day 8.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 3A: SAD Cohort 1 (Japanese) - AZD8965 (Dose 1) Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 3A: SAD Cohort 2 (Japanese) - AZD8965 (Dose 2) Japanese participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 3A: SAD Cohort 3 (Chinese) - AZD8965 (Dose 1) Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 3B: Single and multiple ascending dose (SMAD) Cohort 1 (Japanese) - AZD8965 (Dose 1) 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.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 3B: SMAD Cohort 2 (Chinese) - AZD8965 (Dose 1) 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.	Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally.
Experimental: Part 4: Food Effect Cohort - AZD8965 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)].	Drug: AZD8965 AZD8965 will be administered orally.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]