NCT01100047CompletedPhase 1
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 in Healthy Japanese Subjects After Single and Multiple Ascending Doses
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry
Study Overview
Brief Summary
This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Japanese subjects with suitable veins for cannulation or repeated venepuncture.
- •Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 kg
- •Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product
Exclusion Criteria
- •History of any clinically significant 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.
- •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 significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
- •Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator
Arms & Interventions
1
Experimental
Intervention: AZD5069 (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry
Time Frame: From screening period to follow-up visit 42 days (Maximum)
Secondary Outcomes
- Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose)
- Pharmacokinetic profile: concentration of AZD5069 in blood(Baselines at Visit 1 or pre-dose Day 1, assessments Visit 2, post-dose until 96hr post final dose. Follow up assessments at Visit 3. Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.)
- Measurement of the effect of AZD5069 on blood cells(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Japanese Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic (PK) & Pharmacodynamic (PD) Study of AZD7687ObesityType 2 DiabetesNCT01217905AstraZeneca36
Completed
Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese VolunteersDiabetesDiabetes Mellitus, Type 2NCT01620463Novo Nordisk A/S32
Completed
Phase 1
Safety and Tolerability of Liraglutide in Healthy Japanese VolunteersHealthyDiabetesNCT01620476Novo Nordisk A/S24
Completed
Phase 1
First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19Acute Lung Injury (ALI) Associated With COVID-19Inflammatory Lung Conditions Associated With COVID-19NCT04350736Theravance Biopharma54
Unknown
Phase 1
Safety and Pharmacokinetics of Multiple Dose of YC-6 in Healthy SubjectsIschemic StrokeNCT03358901Guangzhou Cellprotek Pharmaceutical Co., Ltd.32