Trial record 1 of 1 for:
D5133C00001
Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male Volunteers
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01588626
First received: April 26, 2012
Last updated: July 12, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: AZD6140 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of Oral AZD6140 After Single Dose in Healthy Japanese Male Volunteers |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 12 |
| Study Start Date: | May 2012 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AZD6140
single administration of 90 mg dose of AZD6140
|
Drug: AZD6140
tablet
|
Detailed Description:
A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of oral AZD6140 after Single Dose in Healthy Japanese Male Volunteers
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588626
Locations
| Japan | |
| Research Site | |
| Fukuoka, Japan | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Hidenori Komori, MD PHD | AstraZeneca R&D Japan |
| Principal Investigator: | Kyoko Matsuguma | Kyushu Clinical Pharmacology Research Clinic |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01588626 History of Changes |
| Other Study ID Numbers: | D5133C00001 |
| Study First Received: | April 26, 2012 |
| Last Updated: | July 12, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by AstraZeneca:
|
Healthy volunteer Japanese males PK study |
Additional relevant MeSH terms:
|
Ticagrelor Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013