A study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6615 in healthy subjects

Study identifier:D7991C00001

ClinicalTrials.gov identifier:NCT04055168

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase I Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 After Single Dosing to Healthy Subjects

Medical condition

Dyslipidemia

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD6615, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 60 Years

Date

Study Start Date: 24 Jul 2019

Primary Completion Date: 10 Feb 2020

Study Completion Date: 10 Feb 2020

Study design

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

Verification:

Verified 01 Nov 2021 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

1. Provision of signed and dated, written informed consent prior to any study specific procedures.
2. Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non-child-bearing potential.
3. Provision of signed, written and dated informed consent for optional genetic research.
4: In Part 1: Healthy male and/or female Non-Asian subjects aged 20 - 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture. In Part 2: Healthy male and/or female Japanese subjects aged 20 – 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture.
5. Have a body mass index between 18 and 30 kg/m^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at the Screening Visit and Day -1.
6. Males should avoid fathering a child by either true abstinence or a highly effective contraception form of birth control during the study.

Exclusion Criteria

1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
2. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
3. Subjects with known autoimmune disease or on treatment with immune-modulatory drugs.
4. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational medicinal product.
5. Any laboratory values with the following deviations at the Screening Visit and/or Day -1, test may be repeated once for each visit at the discretion of the Investigator if out of range: (Alanine aminotransferase > upper limit of normal [ULN], Aspartate aminotransferase > ULN, Creatinine > ULN, White blood cell count < 3.5 x 10^9/L, Hb < lower limit of normal [LLN], Platelet count
6. Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus.
7. Abnormal vital signs, any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-Lead ECG as considered by the Investigator, that may interfere with the interpretation of QTc interval changes.
8. Known or suspected history of drug abuse, current smoker or those who have smoked or used nicotine products within the previous 3 months before the Screening Visit.
9. History of alcohol abuse and/or severe allergy/hypersensitivity.
10. Previous bone marrow transplant.
11. Males who are unwilling to use an acceptable method of birth control during the entire study period.

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1 - Part 1 On Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 1 of AZD6615 (6 subjects) or matching placebo (2 subjects).	Drug: AZD6615 AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Study drug Drug: Placebo Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Control
Experimental: Cohort 2 - Part 1 On Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 2 of AZD6615 (6 subjects) or matching placebo (2 subjects).	Drug: AZD6615 AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Study drug Drug: Placebo Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Control
Experimental: Cohort 3 - Part 1 On Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 3 of AZD6615 (6 subjects) or matching placebo (2 subjects).	Drug: AZD6615 AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Study drug Drug: Placebo Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Control
Experimental: Cohort 1 - Part 2 On Day 1, randomized subjects (healthy Japanese subjects) will receive dose 1 of AZD6615 (6 subjects) or matching placebo (2 subjects).	Drug: AZD6615 AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Study drug Drug: Placebo Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Control
Experimental: Cohort 2 - Part 2 On Day 1, randomized subjects (healthy Japanese subjects) will receive dose 2 of AZD6615 (6 subjects) or matching placebo (2 subjects).	Drug: AZD6615 AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Study drug Drug: Placebo Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Control

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

David Han

California Clinical Trials Medical Group