HealthyPhase 1NCT01027234
This Study Will Assess the Safety and Tolerability of AZD8418 After Single Increasing Oral Doses
A Phase 1 study testing AZD8418 in people with Healthy, run by AstraZeneca at 1 site in United States.
Trial summary
The main purpose of this study is to assess the safety and tolerability of AZD8418 after single increasing oral doses. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD8418
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Mar 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- Healthy female volunteers of non-childbearing potential
Who cannot join
- History of any clinically significant medical, neurologic, or psychiatric disease (including repeated episodes of major depression) or a disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8418
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single-ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and Pharmacokinetics (Part A) and an Open-label Assessment of the Effect of Food on the Pharmacokinetics (Part B) of Orally Administered AZD8418
The main purpose of this study is to assess the safety and tolerability of AZD8418 after single increasing oral doses.
Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Part B of the study will assess the effect of food on the safety and pharmacokinetics of AZD8418.
- Conditions
- Healthy
- Being tested
- AZD8418, Placebo
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8418Drug
Single oral dose
PlaceboDrug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD8418 |
| 2 | Placebo comparator | Not described 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 AZD8418 following the oral administration of single ascending doses and to estimate the maximum tolerated dose in healthy volunteers.
Measured: Safety assessments will be obtained daily throughout the study
Secondary outcomes (2)
To characterise the pharmacokinetics of AZD8418 and its metabolites in plasma and urine, and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses of AZD8418.
Measured: samples will be obtained pre and post dose
To assess the effect of food on the safety and pharmacokinetic profile of AZD8418 and its metabolites.
Measured: samples will be obtained pre and post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Pre-Clinical Safety Tox Findings
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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip T. Leese, M.D., Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027234
- Sponsor's protocol ID
- D2590C00001
- Status last verified
- May 2010
- First submitted
- 4 Dec 2009
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. 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-ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and Pharmacokinetics (Part A) and an Open-label Assessment of the Effect of Food on the Pharmacokinetics (Part B) of Orally Administered AZD8418
- ClinicalTrials.gov ID
- NCT01027234
- Acronym / sponsor ID
- D2590C00001
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pre-Clinical Safety Tox Findings
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Dec 2009 (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 main purpose of this study is to assess the safety and tolerability of AZD8418 after single increasing oral doses.
Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Part B of the study will assess the effect of food on the safety and pharmacokinetics of AZD8418.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD8418 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers
- Healthy female volunteers of non-childbearing potential
Key exclusion criteria (2 listed)
- History of any clinically significant medical, neurologic, or psychiatric disease (including repeated episodes of major depression) or a disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8418
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 |
|---|---|---|
| AZD8418Single oral dose | Drug | 1 |
| Placebosingle oral dose | Drug | 2 |
Primary outcome
To assess the safety and tolerability of AZD8418 following the oral administration of single ascending doses and to estimate the maximum tolerated dose in healthy volunteers.
Time frame: Safety assessments will be obtained daily throughout the study
2 secondary outcomes
To characterise the pharmacokinetics of AZD8418 and its metabolites in plasma and urine, and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses of AZD8418.
Time frame: samples will be obtained pre and post dose
To assess the effect of food on the safety and pharmacokinetic profile of AZD8418 and its metabolites.
Time frame: samples will be obtained pre and post dose
Results and safety
The study was stopped early (reason given: Pre-Clinical Safety Tox Findings). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
Philip T. Leese, M.D. principal investigator
Quintiles, Inc.
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 AZD8418 in people with 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 May 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 was stopped early (reason given: Pre-Clinical Safety Tox Findings). Results are not available in the source record.
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 AZD8418 following the oral administration of single ascending doses and to estimate the maximum tolerated dose in healthy volunteers. (time frame: Safety assessments will be obtained daily throughout 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 26 May 2010.