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Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01588626
First received: April 26, 2012
Last updated: July 12, 2012
Last verified: July 2012
History of Changes

April 26, 2012
July 12, 2012
May 2012
June 2012   (final data collection date for primary outcome measure)
  • Description of pharmacokinetics for AZD6140 in terms of: Cmax, tmax, t½, AUC(0-t), AUC, CL/F, Vz/F, MRT, and AUC and Cmax ratios of AR-C124910XX to AZD6140, following single administration of 90 mg dose of AZD6140 in healthy Japanese volunteers. [ Time Frame: From day 1 (pre-dose) till Day 4 (72h) ] [ Designated as safety issue: No ]
    Maximum Concentration (Cmax), Time to reach maximum (peak) plasma concentration (tmax), Terminal plasma half-life (t½), Area under the plasma concentration-time curve from time zero to time t (AUC(0-t)),Area under the plasma concentration-time curve (AUC), Apparent total clearance of the drug from plasma after oral administration (CL/F), Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F), Mean residence time (MRT), and AUC and Cmax ratios of AR-C124910XX to AZD6140,
  • Description of pharmacokinetics profile for AR-C124910XX, which is AZD6140 active metabolite, in terms of: Cmax, tmax, t½, AUC(0-t), AUC, CL/F, Vz/F, MRT, and AUC, following single administration of 90 mg dose of AZD6140 in healthy Japanese volunteers. [ Time Frame: From day 1 (pre-dose) till Day 4 (72h) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01588626 on ClinicalTrials.gov Archive Site
AZD6140 Safety and tolerability profile in terms of: adverse events, vital signs (blood pressure and pulse rate), electrocardiograms (ECGs), laboratory variables [ Time Frame: From Day -1 (pre-dose) up to 7-10 days after dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male Volunteers
A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of Oral AZD6140 After Single Dose in Healthy Japanese Male Volunteers

The purpose of this study is to assess the pharmacokinetics of AZD6140 and its active metabolite, safety, tolerability of AZD6140 following single administration in healthy male Japanese volunteers.

A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of oral AZD6140 after Single Dose in Healthy Japanese Male Volunteers
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: AZD6140
tablet
Experimental: AZD6140
single administration of 90 mg dose of AZD6140
Intervention: Drug: AZD6140
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subject aged between 20 to 45 years inclusive
  • Body mass index (BMI=weight/height2) between 18.0 to 27.0 kg/m2 inclusive
  • Body weight between 50.0 to 85.0 kg inclusive Provision of written informed consent

Exclusion Criteria:

  • Clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator, or positive results on screening tests for serum hepatitis B surface antigen and hepatitis C antibody, syphilis and human immu
  • Supine blood pressure > 150 mmHg systolic or > 95 mmHg diastolic or supine pulse > 90 beats per minute (after resting for 10 minutes) Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
  • Personal or familial predisposition for thrombotic disorders Clinically significant medical history, including psychiatric disorders and severe allergies
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01588626
D5133C00001
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Hidenori Komori, MD PHD AstraZeneca R&D Japan
Principal Investigator: Kyoko Matsuguma Kyushu Clinical Pharmacology Research Clinic
AstraZeneca
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP