A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants
Recruiting
Phase 1Interventional Study
Healthy Participants
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
176 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for healthy men and women to evaluate the safety and effects of a drug called AZD3974. Participants must meet certain health criteria and will take the drug to help researchers understand how it works in the body.
Are You a Good Fit for This Trial?
You may be able to join if
I am a healthy male or female and do not have childbearing potential.
I weigh at least 50 kg.
My body mass index is between 18 and 32.
I have suitable veins for blood draws.
I have a negative pregnancy test if I am female.
I am of Japanese descent if in certain groups.
I am of Chinese descent if in certain groups.
You may not be able to join if
I have a history of serious diseases that could affect my participation.
I have a history or current issues with my stomach, liver, or kidneys.
I have had any serious medical issues or surgeries in the last 4 weeks.
My lab tests or vital signs show significant problems.
I tested positive for hepatitis B, hepatitis C, or HIV.
I have a history of drug or alcohol abuse.
I have severe allergies or hypersensitivity issues.
I have taken AZD3974 before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to assess the safety and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture at the Screening Visit.
* All females must have a negative pregnancy test. Females of non-childbearing potential must be confirmed via post-menopau…
Inclusion Criteria:
* Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture at the Screening Visit.
* All females must have a negative pregnancy test. Females of non-childbearing potential must be confirmed via post-menopausal status or documentation of irreversible surgical sterilization at the Screening Visit.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
* Have a body mass index between 18 and 32 kg/m2 inclusive and weigh at least 50 kg at Screening.
* For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese (eg, natives of Japan or Japan Americans), defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
* For healthy Chinese cohort (Part A3): healthy male and female Chinese participants for whom both parents and 4 grandparents are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China.
Exclusion Criteria:
* History of any clinically important disease or disorder which, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* Any abnormal laboratory values, vital signs, or any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
* Any positive result on Screening for serum hepatitis B and C viruses and human immunodeficiency virus.
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiography at Screening and/or admission to the Clinical Unit .
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
* Positive screen for drugs of abuse, or alcohol, or cotinine.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
* Participants who have previously received AZD3974.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.