TolerabilityPhase 1NCT01154621
Assessing the Safety and Tolerability of a Single IV Dose of AZD9742 in Healthy Elderly Male and Female Subjects
A Phase 1 study testing AZD9742 in people with Tolerability and Healthy, run by AstraZeneca at 1 site in United States.
Trial summary
The aim of this study is to examine the safety and tolerability of a single dose of AZD9742 in elderly individuals. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tolerability, Healthy, Elderly
- What is being tested?
- AZD9742
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jul 2010
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male and female volunteers at age of 65 years or older with suitable veins for cannulation or repeated venipuncture, in good health (based on medical history and physical examination and clinical laboratory tests) as judged by the investigator.
- Female volunteers must be postmenopausal (cessation of regular menses for 12 months and a follicle stimulating hormone level of more than 40IU/L abd estradiol of less than 20ng/mL.
- Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
- History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double-blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability, and Pharmacokinetics of a Single Dose of AZD9742 in Healthy Elderly Male and Female Volunteers
The aim of this study is to examine the safety and tolerability of a single dose of AZD9742 in elderly individuals.
- Conditions
- Tolerability, Healthy, Elderly
- Being tested
- AZD9742, Placebo
- Keywords
- Phase I, Double-blind, Randomized, Placebo-controlled study, Safety and tolerability of single intravenous dose of AZD9742 in healthy elderly volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9742Drug
Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL
PlaceboDrug
Sterile 5% dextrose solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single dose of 750mg of intravenous AZD9742 in healthy elderly volunteers Receives: Drug: AZD9742 |
| 2 | Placebo comparator | Sterile 5% dextrose solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults.
Adverse events, vital signs, electrocardiograms, telemetry, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment
Measured: The screening period is up to 28 days. Residential period will be a total of 5 days. Follow up will occur between 5 and 10 days after discharge.
Secondary outcomes (1)
To evaluate the pharmacokinetics of a single intravenous dose of AZD9742 in healthy elderly volunteers
Measured: Blood and urine samples will be collected for the 4 days while in residence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TolerabilityStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Billings W Billings, MD, Principal investigator, Bio-Kinetic 1816 W. Mt Vernon, Springfield, MO 65802Colleen Jensen, Study director, AstraZenecaBrendan Smyth, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154621
- Sponsor's protocol ID
- D2690C00007
- Status last verified
- Aug 2010
- First submitted
- 28 Jun 2010
- Last updated
- 3 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability, and Pharmacokinetics of a Single Dose of AZD9742 in Healthy Elderly Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT01154621
- Acronym / sponsor ID
- D2690C00007
- Conditions
- Tolerability, Healthy, Elderly
- Keywords
- Phase I, Double-blind, Randomized, Placebo-controlled study, Safety and tolerability of single intravenous dose of AZD9742 in healthy elderly volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Jul 2010 (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 aim of this study is to examine the safety and tolerability of a single dose of AZD9742 in elderly individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD9742Single dose of 750mg of intravenous AZD9742 in healthy elderly volunteers |
| 2 | Placebo comparator | Drug: PlaceboSterile 5% dextrose solution |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Male and female volunteers at age of 65 years or older with suitable veins for cannulation or repeated venipuncture, in good health (based on medical history and physical examination and clinical laboratory tests) as judged by the investigator.
- Female volunteers must be postmenopausal (cessation of regular menses for 12 months and a follicle stimulating hormone level of more than 40IU/L abd estradiol of less than 20ng/mL.
- Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
Key exclusion criteria (3 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
- History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
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 |
|---|---|---|
| AZD9742Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL | Drug | 1 |
| PlaceboSterile 5% dextrose solution | Drug | 2 |
Primary outcome
To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults.
Time frame: The screening period is up to 28 days. Residential period will be a total of 5 days. Follow up will occur between 5 and 10 days after discharge.
Adverse events, vital signs, electrocardiograms, telemetry, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment
1 secondary outcome
To evaluate the pharmacokinetics of a single intravenous dose of AZD9742 in healthy elderly volunteers
Time frame: Blood and urine samples will be collected for the 4 days while in residence.
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 3 Aug 2010.
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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.
Billings W Billings, MD principal investigator
Bio-Kinetic 1816 W. Mt Vernon, Springfield, MO 65802
Colleen Jensen study director
AstraZeneca
Brendan Smyth study chair
AstraZeneca
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 AZD9742 in people with Tolerability and Healthy, run by AstraZeneca at 1 site 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 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 3 Aug 2010. 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 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?
To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults. (time frame: The screening period is up to 28 days. Residential period will be a total of 5 days. Follow up will occur between 5 and 10 days after discharge.). 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 3 Aug 2010.