Title
AZD1386 Japanese Multiple Ascending Dosing Study
A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Japanese Young and Elderly Subjects After Oral Multiple Doses.
Phase
Phase 1Lead Sponsor
AstraZenecaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Chronic PainIntervention/Treatment
azd1386 ...Study Participants
32This is a single centre, double-blind, randomised, parallel group, placebo controlled study to assess the safety, tolerability and pharmacokinetics of AZD1386 when given as multiple doses to 32 (24 healthy young and 8 healthy elderly) Japanese subjects. For young healthy subjects (aged ≥20 to ≤45 inclusive) 3 consecutive multiple ascending dose panels are planned. For elderly healthy subjects (aged ≥65 to≤80 inclusive) 1 multiple dose panel is planned.
Oral admin. of doses at 11 days through a 12 days period.
Oral admin. of doses at 11 days through a 12 days period.
Inclusion Criteria: Healthy Japanese males or females young (≥20 to ≤45 years inclusive) or elderly (≥65 to ≤80 years inclusive). Female subjects must be surgically sterile or post-menopausal. Body Mass Index (BMI) of ≥19 to ≤ 27 kg/m2 and weight of ≥45 to ≤90 kg Clinically normal physical findings including heart rate > 45 bpm and laboratory values and normal resting ECG Exclusion Criteria: History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator A family history of short or long QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives Subjects with orthostatic hypotension defined as a decrease of ≥ 25mmHg systolic blood pressure and/or a decrease of ≥15mmHg diastolic blood pressure within 5 minutes when going from a supine to standing position Clinically significant illness or clinically relevant trauma within 2 weeks prior to the administration of the investigational product as judged by the investigator
