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Completed

NCT Number: NCT01116011

Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers

This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Kanagawa, Sagamihara, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of Informed Consent
  • Healthy male subjects, with suitable veins for cannulation or repeated venipuncture

Exclusion criteria

  • Inability to understand or cooperate with given information
  • Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
  • History of seizure (including infant febrile seizures) or family history of seizure

Treatment and study plan

AZD7268

Drug

Capsule, Oral, BID

Placebo

Drug

Capsule, Oral, BID

Primary outcomes

  1. Investigate the safety and tolerability of AZD7268 by Adverse Events.

    Time frame: From first dosing throughout the treatment period and including the follow-up period

Secondary outcomes

  1. Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma

    Time frame: Blood samples will be taken from pre-dose until 48 hours post last dose

  2. Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine

    Time frame: Urine samples will be taken from post first dose until 48 hours post last dose.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Japanese Healthy Male Subjects

Acronym: JMAD

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 4, 2010
Registry last updated
Dec 15, 2010

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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