Clinical trial NCT01233830: Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy Japanese Volunteers
Official title: A Phase I, Single Centre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 Solution After Administration of Multiple Ascending Doses for 12 Days in Young and Elderly Healthy Japanese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety, tolerability, pharmacokinetics, AZD2423, Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423 in young and elderly healthy Japanese volunteers.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy Japanese male volunteers aged ≥20 to ≤45 years and healthy Japanese male and female volunteers aged ≥65 to ≤80 years with suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between ≥17 and ≤27 kg/m2, as calculated by the investigator(s), and weigh at least 45 kg and no more than 100 kg
* Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the investigator(s)

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator(s), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer'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 investigator(s), within 3 months of the first administration of investigational product or known malignancy within the past 5 years (with the exception of successfully treated basal cell carcinoma)

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
measure: Vital signs
timeFrame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
measure: Electrocardiograms
timeFrame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
measure: Laboratory Variables (hematology, urinalysis and clinical chemistry)
timeFrame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Secondary outcomes:
measure: Plasma concentration over time
timeFrame: Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours after the first dose
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje
name: Bror Jonzon, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kyushu Clinical Pharmacology Research Clinic
name: Akimasa Watanabe
role: PRINCIPAL_INVESTIGATOR
References: