HealthyPhase 1NCT01588626
Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male Volunteers
A Phase 1 study testing AZD6140 in people with Healthy, run by AstraZeneca at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD6140
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- May 2012to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of oral AZD6140 after Single Dose in Healthy Japanese Male Volunteers
- Conditions
- Healthy
- Being tested
- AZD6140
- Keywords
- Healthy volunteer, Japanese males, PK study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6140Drug
tablet
| Study group | Role | What they receive |
|---|---|---|
| AZD6140 | Experimental | single administration of 90 mg dose of AZD6140 Receives: Drug: AZD6140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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,
Measured: From day 1 (pre-dose) till Day 4 (72h)
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.
Measured: From day 1 (pre-dose) till Day 4 (72h)
Secondary outcomes (1)
AZD6140 Safety and tolerability profile in terms of: adverse events, vital signs (blood pressure and pulse rate), electrocardiograms (ECGs), laboratory variables
Measured: From Day -1 (pre-dose) up to 7-10 days after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hidenori Komori, MD PHD, Study director, AstraZeneca R&D JapanKyoko Matsuguma, Principal investigator, Kyushu Clinical Pharmacology Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588626
- Sponsor's protocol ID
- D5133C00001
- Status last verified
- Jul 2012
- First submitted
- 26 Apr 2012
- Last updated
- 13 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of Oral AZD6140 After Single Dose in Healthy Japanese Male Volunteers
- ClinicalTrials.gov ID
- NCT01588626
- Acronym / sponsor ID
- D5133C00001
- Conditions
- Healthy
- Keywords
- Healthy volunteer, Japanese males, PK study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD6140 | Experimental | Drug: AZD6140single administration of 90 mg dose of AZD6140 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD6140tablet | Drug | AZD6140 |
Primary outcome
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)
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hidenori Komori, MD PHD study director
AstraZeneca R&D Japan
Kyoko Matsuguma principal investigator
Kyushu Clinical Pharmacology Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6140 in people with Healthy, run by AstraZeneca at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.