Healthy Participants
Conditions
Keywords
Single-ascending dose, Multiple-ascending dose, Pharmacokinetics
Brief summary
The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants.
Detailed description
This is a single-blind, placebo-controlled study conducted at a single clinical unit. The study will comprise of: * Part 1: Single ascending dose (SAD) part (part 1a) and a Multiple ascending dose (MAD) part (part 1b), both in global participants. * Part 2: SAD part (part 2a) and a MAD part (part 2b) specifically for Japanese and Chinese participants only.
Interventions
DRUGAZD4916
AZD4916 will be administered as oral solution.
OTHERPlacebo
Placebo will be administered as oral solution.
Sponsors
AstraZeneca
Parexel
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria: * Healthy male and female participants with suitable veins for cannulation or repeated venipuncture. * All females must have negative pregnancy test and females of childbearing potential must not be lactating and must agree to use an approved method of highly effective contraception. * Have a Body Mass Index between 18 and 30 kg/m2 inclusive and weigh at least 45 kg at Screening. * Part 2, Japanese participants only: Japanese participants must have been born in Japan, have 2 Japanese biological parents and 4 Japanese grandparents (as confirmed by the interview), and must not have lived outside of Japan for more than 10 years at the time of the Screening Visit. * Part 2, Chinese participants only: Chinese participants must have been born in China (including Hong Kong, Macau, and Taiwan), have 2 Chinese biological parents and 4 Chinese grandparents (as confirmed by the interview), and must not have lived outside of China for more than 10 years at the time of the Screening Visit. Main
Exclusion criteria
* History of any clinically important disease or disorder which, in the opinion of the Principal Investigator, 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. * History of chest irradiation, fibrosis, malignancy, surgical procedure, trauma or liver disease. * Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results. * Evidence of active tuberculosis or Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection. * Abnormal vital signs or clinically important abnormalities in rhythm. * Current smokers, known or suspected history of alcohol, drug abuse or caffeine intake. * History of severe allergy/hypersensitivity. * Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss \> 500 mL during the 3 months prior to the Screening Visit. * Participants who are vegans or have dietary restrictions. * Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) | From Screening (Day -29 to Day -2) up to 44 days | The safety and tolerability of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses to healthy participants (including Japanese and Chinese) will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under concentration-time curve from time zero to infinity (AUCinf) | Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24 | The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised. |
| Maximum observed drug concentration (Cmax) | Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24 | The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised. |
| Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24 | The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised. |
| Area under concentration-time curve in the dosing interval (AUCtau) | Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24 | The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised. |
Countries
United Kingdom, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed