A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AZD3974, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD3974 After Single and Multiple Ascending Dosing to Healthy Participants
Overview
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.
Detailed description
This is a first in human, randomized, single-blind, placebo-controlled study. It consists of two parts.
Part A (single ascending dose - SAD): This study part will enroll six cohorts (plus two optional additional cohorts) of healthy participants (Part A1), three cohorts (plus one optional additional cohort) of healthy Japanese participants (Part A2) and one cohort (plus one optional additional cohort) of healthy Chinese participants (Part A3). Cohort 3 of Part A1 will be extended to evaluate the effect of food intake on the PK of AZD3974. In Part A (all cohorts), participants will receive a single dose of AZD3974 or placebo.
Part B (Multiple Ascending Dose - MAD): This study part will consist of four cohorts (plus two optional additional cohorts) of healthy participants (Part B1) and one cohort (plus one optional additional cohort) of healthy Japanese participants (Part B2). In all Part B cohorts, participants will receive multiple doses of AZD3974 or placebo.
Both Part A and Part B will comprise of:
* A Screening Period of maximum 28 days * A Dosing session during which participants will receive the study intervention at study specific time points. * Follow-up Period of 7 days post last-dose.
Interventions
- Drug AZD3974
AZD3974 will be administered as an oral solution. - Other Placebo
Placebo will be administered as an oral solution.
Primary outcome measures
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Time frame: Part A: Upto Day 7; Part A1 Cohort 3: Upto Day 10; Part B: Upto Day 14]
Secondary outcome measures (12)
- Part A and Part B: Plasma concentrations of AZD3974 [Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9]
- Part A1-Cohort 3: Plasma concentrations of AZD3974 [Time frame: Day 1 to Day 4]
- Part A and Part B: Urine concentrations of AZD3974 [Time frame: Part A: Day 1; Part B: Day 1 and Day 7]
- Part A1-Cohort 3: Urine concentrations of AZD3974 [Time frame: Day 1 and Day 3]
- Part A and Part B: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) [Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9]
- Part A1-Cohort 3: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) [Time frame: Day 1 to Day 4]
- Part A: Area under concentration-time curve from time 0 to infinity (AUCinf) [Time frame: Day 1 to Day 2]
- Part A1-Cohort 3: Area under concentration-time curve from time 0 to infinity (AUCinf) [Time frame: Day 1 to Day 4]
- Part A and Part B: Maximum observed drug concentration (Cmax) [Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9]
- Part A1-Cohort 3: Maximum observed drug concentration (Cmax) [Time frame: Day 1 to Day 4]
- Part A and Part B: Time to reach maximum observed concentration (tmax) [Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9]
- Part A1-Cohort 3: Time to reach maximum observed concentration (tmax) [Time frame: Day 1 to Day 4]
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-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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Research Site — Glendale
- Research Site — Baltimore
Identifiers
NCT: NCT07290283 · D7360C00001