HealthyPhase 1JSAD/JMADNCT00785915
AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects
A Phase 1 study testing AZD6765 in people with Healthy, run by AstraZeneca at 2 sites in United States.
Trial summary
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD6765
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Mar 2009
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI): 18 to 27 kg/m 2
- Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening.
- Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.
Who cannot join
- Clinically relevant disease and/or abnormalities (past or present)
- Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
- Use of any prescription medication within 14 days of Day 1
- Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1
- Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Baltimore, Maryland
Research Site
Glendale, California
About this study
Official title: A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6765 in Healthy Male and Female Japanese and Caucasian Subjects
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects
- Conditions
- Healthy
- Being tested
- AZD6765, Placebo
- Keywords
- AZD6765, Japanese and Caucasian Healthy Volunteers, Phase I study, Single and multiple Ascending Dose, Japanese volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6765Drug
single administration and once daily for 5 days
PlaceboDrug
single administration and once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD6765 |
| 2 | Placebo comparator | given (2 subjects in each ethnic/dose group) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments
Measured: During the study
Secondary outcomes (2)
Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine
Measured: During residential period
Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765.
Measured: During the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionMar 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Yen, MD, Principal investigator, California Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785915
- Sponsor's protocol ID
- D6702C00013
- Acronym
- JSAD/JMAD
- Status last verified
- Oct 2014
- First submitted
- 3 Nov 2008
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6765 in Healthy Male and Female Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT00785915
- Acronym / sponsor ID
- JSAD/JMAD / D6702C00013
- Conditions
- Healthy
- Keywords
- AZD6765, Japanese and Caucasian Healthy Volunteers, Phase I study, Single and multiple Ascending Dose, Japanese volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 5 Nov 2008 (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.
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD6765 |
| 2 | Placebo comparator | Drug: Placebogiven (2 subjects in each ethnic/dose group) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI): 18 to 27 kg/m 2
- Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening.
- Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.
Key exclusion criteria (5 listed)
- Clinically relevant disease and/or abnormalities (past or present)
- Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
- Use of any prescription medication within 14 days of Day 1
- Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1
- Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1
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 |
|---|---|---|
| AZD6765single administration and once daily for 5 days | Drug | 1 |
| Placebosingle administration and once daily for 5 days | Drug | 2 |
Primary outcome
Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments
Time frame: During the study
2 secondary outcomes
Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine
Time frame: During residential period
Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765.
Time frame: During the study
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 Oct 2014.
- D6702C00013 Clinical Study Report SynopsisLink provided by the sponsor.
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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.
Mark Yen, MD principal investigator
California Clinical Trials
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6765 in people with Healthy, run by AstraZeneca at 2 sites in United States.
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 5 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 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments (time frame: During the study). 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 Oct 2014.