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

Healthy Clinical Trial

— JMAD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116011
• Other study ID #: D1151C00004
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2010
• Last updated: December 14, 2010
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD7268
Capsule, Oral, BID
• Placebo
Capsule, Oral, BID

Locations

Country	Name	City	State
Japan	Research Site	Kanagawa	Sagamihara

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the safety and tolerability of AZD7268 by Adverse Events.		From first dosing throughout the treatment period and including the follow-up period	Yes
Secondary	Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma		Blood samples will be taken from pre-dose until 48 hours post last dose	No
Secondary	Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine		Urine samples will be taken from post first dose until 48 hours post last dose.	No