PharmacokineticsPhase 1NCT00714337
Formulation and Food Effect Study of AZD1386 in Healthy Volunteers
A Phase 1 study testing AZD1386 in people with Pharmacokinetics, run by AstraZeneca.
Trial summary
To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- AZD1386
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Aug 2008
- 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
- Females must be non-fertile (Amenorrhea and no pregnancy in the last 12 months prior to enrolment or documentation of being irreversible surgically sterile).
- Healthy male volunteers with BMI between 18 and 30 kg/m2
- Clinical normal physical findings, including blood pressure, pulse rate above 45 bpm, ECG, and laboratory assessments.
- Normal QTc interval on baseline ECG, between 360-450 msec, according to the Fridericia formula.
Who cannot join
- History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity as judged by the Investigator.
- Requirement of concomitant medication during the study, excluding hormone replacement therapy (HRT) or use of drugs with enzyme inducing properties with 3 weeks of first dose
- Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before first administration of study drug
- A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives and who have a QT/QTc <360 ms
About this study
Official title: A Phase I, Single-Centre, Randomised, Open-Label, Five-Way Cross-Over Formulation- and Food-Effect Study in Healthy Volunteers to Assess the Pharmacokinetics of AZD1386 After Single Doses of Two Oral Solid Formulations and an Oral Solution
To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.
- Conditions
- Pharmacokinetics
- Being tested
- AZD1386
- Keywords
- Formulation, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1386Drug
One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).
AZD1386Drug
One single oral dose of 90mg (3 x 30mg AZD1386 capsules)
AZD1386Drug
One single oral dose of 90mg (6 x 15mg AZD1386 tablets)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | fasting state Receives: Drug: AZD1386 |
| 2 | Experimental | fasting state Receives: Drug: AZD1386 |
| 3 | Experimental | non-fasting state Receives: Drug: AZD1386 |
| 4 | Experimental | fasting state Receives: Drug: AZD1386 |
| 5 | Experimental | non-fasting state Receives: Drug: AZD1386 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK variables
Measured: Frequent sampling occasions during study days
Secondary outcomes (1)
Safety variables (adverse events, blood pressure, pulse, safety lab)
Measured: During the whole treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klaus Francke, MD, Principal investigator, PAREXEL Clinical Pharmacology Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714337
- Sponsor's protocol ID
- D5090C00007
- Other IDs
- EudraCT 2008-002150-37
- Status last verified
- Dec 2010
- First submitted
- 10 Jul 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Centre, Randomised, Open-Label, Five-Way Cross-Over Formulation- and Food-Effect Study in Healthy Volunteers to Assess the Pharmacokinetics of AZD1386 After Single Doses of Two Oral Solid Formulations and an Oral Solution
- ClinicalTrials.gov ID
- NCT00714337
- Acronym / sponsor ID
- D5090C00007
- Conditions
- Pharmacokinetics
- Keywords
- Formulation, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Jul 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.
To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1386fasting state |
| 2 | Experimental | Drug: AZD1386fasting state |
| 3 | Experimental | Drug: AZD1386non-fasting state |
| 4 | Experimental | Drug: AZD1386fasting state |
| 5 | Experimental | Drug: AZD1386non-fasting state |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females must be non-fertile (Amenorrhea and no pregnancy in the last 12 months prior to enrolment or documentation of being irreversible surgically sterile).
- Healthy male volunteers with BMI between 18 and 30 kg/m2
- Clinical normal physical findings, including blood pressure, pulse rate above 45 bpm, ECG, and laboratory assessments.
- Normal QTc interval on baseline ECG, between 360-450 msec, according to the Fridericia formula.
Key exclusion criteria (4 listed)
- History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity as judged by the Investigator.
- Requirement of concomitant medication during the study, excluding hormone replacement therapy (HRT) or use of drugs with enzyme inducing properties with 3 weeks of first dose
- Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before first administration of study drug
- A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives and who have a QT/QTc <360 ms
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 |
|---|---|---|
| AZD1386One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution). | Drug | 1 |
| AZD1386One single oral dose of 90mg (3 x 30mg AZD1386 capsules) | Drug | 2, 3 |
| AZD1386One single oral dose of 90mg (6 x 15mg AZD1386 tablets) | Drug | 4, 5 |
Primary outcome
PK variables
Time frame: Frequent sampling occasions during study days
1 secondary outcome
Safety variables (adverse events, blood pressure, pulse, safety lab)
Time frame: During the whole treatment period
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 10 Dec 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.
Klaus Francke, MD principal investigator
PAREXEL Clinical Pharmacology Research Unit
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD1386 in people with Pharmacokinetics, run by AstraZeneca.
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 4 inclusion and 4 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 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
PK variables (time frame: Frequent sampling occasions during study days). 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 10 Dec 2010.