Clinical trial NCT01588626: Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male Volunteers
Official title: A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of Oral AZD6140 After Single Dose in Healthy Japanese Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
Japanese males
PK study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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 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

Primary outcomes:
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.
timeFrame: From day 1 (pre-dose) till Day 4 (72h)
measure: 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.
timeFrame: From day 1 (pre-dose) till Day 4 (72h)
Secondary outcomes:
measure: AZD6140 Safety and tolerability profile in terms of: adverse events, vital signs (blood pressure and pulse rate), electrocardiograms (ECGs), laboratory variables
timeFrame: From Day -1 (pre-dose) up to 7-10 days after dose
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Japan
name: Hidenori Komori, MD PHD
role: STUDY_DIRECTOR
affiliation: Kyushu Clinical Pharmacology Research Clinic
name: Kyoko Matsuguma
role: PRINCIPAL_INVESTIGATOR
References: