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Completed

NCT Number: NCT00696865

AZD2624 Multiple Ascending Dose Study in Japan

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

Completed

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Key information

Conditions

Healthy Safety

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Kanagawa, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy young male Japanese volunteers

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

Treatment and study plan

AZD2624

Drug

oral suspension, 3 doses

Placebo

Drug

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

    Time frame: All assessments are made at each visit, at least daily, during the study.

Secondary outcomes

  1. 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

    Time frame: Blood samples will be taken before and after study drug administration.

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

    Time frame: A single blood sample will be obtained

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2624 When Given in Multiple Ascending Oral Doses in Young Healthy Male Japanese Subjects

Acronym: JMAD

Important dates

Study start
2008
Study completion
2008
First posted
Jun 13, 2008
Registry last updated
Jul 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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