AZD2624 Multiple Ascending Dose Study in Japan

NCT00696865 | Completed Phase 1

• 1 other identifier: D0970C00006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Safety

Keywords

Safety; Tolerability; Phase I

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

• Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624

  A single blood sample will be obtained

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD2624

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD2624 DRUG

oral suspension, 3 doses

1

Placebo DRUG

2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy young male Japanese volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Kanagawa, Japan

Location

MeSH Terms

Interventions

3-((methylsulfonyl)amino)-2-phenyl-N-(1-phenylpropyl)quinolin-4-carboxamide

Study Officials

• Yuji Kumagai, MD, PhD

  Kitasato University East Hospital, Kanagawa, Japan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: May 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 16, 2009

Record last verified: 2009-07

Locations

JP (1)