AZD2624 Multiple Ascending Dose Study in Japan

Phase 1

Completed

• Conditions: Healthy; Safety
• Interventions: Drug: AZD2624; Drug: Placebo

• Registration Number: NCT00696865
• Lead Sponsor: AstraZeneca

Brief Summary

This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Study Completion: 2008-08
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-15
• Last Update Posted: 2009-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Healthy young male Japanese volunteers

Read More

Exclusion Criteria

• Significant illness, as judged by the investigator, within 2 weeks of screening visit or Day 1
• Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit or Day 1
• Blood loss in excess of 200 mL within 30 days of screening visit or Day 1, in excess of 400 mL within 90 days of screening visit or Day 1, or in excess of 1200 mL within 1 year of screening visit or Day 1
• Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator at screening or pre first dose

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD2624	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs	All assessments are made at each visit, at least daily, during the study.

Secondary Outcome Measures

Name	Time	Method
Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624	A single blood sample will be obtained
To evaluate and characterize the pharmacokinetics of AZD2624 and its metabolites when given orally in multiple ascending doses of AZD2624 to young healthy male Japanese subjects by assessment of drug concentration in plasma	Blood samples will be taken before and after study drug administration.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Kanagawa, Japan