Healthy VolunteersPhase 1NCT01951599
To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.
A Phase 1 study testing AZD9291 in people with Healthy Volunteers, run by AstraZeneca at 1 site in United States.
Trial summary
To determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AZD9291
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2013to 4 Jun 2014
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1, Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg. 2, Volunteers must be willing to use a condom, unless their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. 3. In addition, volunteers must agree to continue to take similar contraceptive precautions until 4 months after the last dose of AZD9291.
Who cannot join
- Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
- Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to dosing.
- History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to AZD9291, its excipients, or drugs with a similar chemical structure or class.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food
To determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers.
Read the detailed description
A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food
- Conditions
- Healthy Volunteers
- Being tested
- AZD9291
- Keywords
- Phase I, healthy, bioavailability, pharmacokinetics, safety, tolerability.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9291Drug
Volunteers will receive a single 20-mg dose of AZD9291 as a capsule on day 1, in Part A, Period 1, in the fasted state. (Treatment A).
AZD9291Drug
Volunteers will receive a single 20-mg dose of AZD9291 as a solution on day 1, in Part A, Period 2, in the fasted state. (Treatment B).
AZD9291Drug
Volunteers will receive a single 20-mg dose of AZD9291 as a tablet on day 1, in Part A, Period 3, in the fasted state. (Treatment C).
AZD9291Drug
Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 1, in the fasted state.
AZD9291Drug
Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 2, in the fed state.
| Study group | Role | What they receive |
|---|---|---|
| AZD9291 20mg (oral capsule fasted) | Experimental | Volunteers will receive AZD9291 20mg administered by mouth, as a capsule, in the fasted state. Receives: Drug: AZD9291 |
| AZD9291 20mg (oral solution fasted) | Experimental | Volunteers will receive AZD9291 20mg administered by mouth, as a solution, in the fasted state. Receives: Drug: AZD9291 |
| AZD9291 20mg (oral tablet fasted) | Experimental | Volunteers will receive AZD9291 20mg administered by mouth, as a tablet, in the fasted state. Receives: Drug: AZD9291 |
| AZD9291 20mg (oral fasted) | Experimental | Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fasted state. Receives: Drug: AZD9291 |
| AZD9291 20mg (oral fed) | Experimental | Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fed state. Receives: Drug: AZD9291 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of AZD9291 and its metabolites, by assessment of maximum plasma concentration (Cmax)
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Secondary outcomes (10)
Pharmacokinetics of AZD9291 and its metabolites by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of time to Cmax (tmax)
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of Terminal rate constant (λz)
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of Terminal half life (t1/2,λz)
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of lag time before observation of quantifiable analyte concentrations in plasma (tlag)
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of area under the plasma concentration-time curve from zero to time of last measurable concentration [AUC(0-t)]
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of area under the plasma concentration-time curve from zero to 72 hours [AUC(0-72)]
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 only, by assessment of apparent plasma clearance (CL/F).
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 only, apparent volume of distribution (Vz/F)
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 parent to metabolite ratio (calculated for both Cmax and AUC).
Curve taken during each of the 5 treatments
Measured: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study start9 Oct 2013
- Primary completion4 Jun 2014
- Study completion4 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phil Leese, MD, Principal investigator, Quintiles 6700 W 115th Street, Kansas, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951599
- Sponsor's protocol ID
- D5160C00005
- Status last verified
- Mar 2017
- First submitted
- 24 Sep 2013
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food
- ClinicalTrials.gov ID
- NCT01951599
- Acronym / sponsor ID
- D5160C00005
- Conditions
- Healthy Volunteers
- Keywords
- Phase I, healthy, bioavailability, pharmacokinetics, safety, tolerability.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2013 (actual)
- Primary completion
- 4 Jun 2014 (actual)
- Study completion
- 4 Jun 2014 (actual)
- First posted
- 26 Sep 2013 (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 determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers.
Detailed description
A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AZD9291 20mg (oral capsule fasted) | Experimental | Drug: AZD9291Volunteers will receive AZD9291 20mg administered by mouth, as a capsule, in the fasted state. |
| AZD9291 20mg (oral solution fasted) | Experimental | Drug: AZD9291Volunteers will receive AZD9291 20mg administered by mouth, as a solution, in the fasted state. |
| AZD9291 20mg (oral tablet fasted) | Experimental | Drug: AZD9291Volunteers will receive AZD9291 20mg administered by mouth, as a tablet, in the fasted state. |
| AZD9291 20mg (oral fasted) | Experimental | Drug: AZD9291Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fasted state. |
| AZD9291 20mg (oral fed) | Experimental | Drug: AZD9291Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fed state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1, Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg. 2, Volunteers must be willing to use a condom, unless their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. 3. In addition, volunteers must agree to continue to take similar contraceptive precautions until 4 months after the last dose of AZD9291.
Key exclusion criteria (3 listed)
- Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
- Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to dosing.
- History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to AZD9291, its excipients, or drugs with a similar chemical structure or class.
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 |
|---|---|---|
| AZD9291Volunteers will receive a single 20-mg dose of AZD9291 as a capsule on day 1, in Part A, Period 1, in the fasted state. (Treatment A). | Drug | AZD9291 20mg (oral capsule fasted) |
| AZD9291Volunteers will receive a single 20-mg dose of AZD9291 as a solution on day 1, in Part A, Period 2, in the fasted state. (Treatment B). | Drug | AZD9291 20mg (oral solution fasted) |
| AZD9291Volunteers will receive a single 20-mg dose of AZD9291 as a tablet on day 1, in Part A, Period 3, in the fasted state. (Treatment C). | Drug | AZD9291 20mg (oral tablet fasted) |
| AZD9291Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 1, in the fasted state. | Drug | AZD9291 20mg (oral fasted) |
| AZD9291Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 2, in the fed state. | Drug | AZD9291 20mg (oral fed) |
Primary outcome
Pharmacokinetics of AZD9291 and its metabolites, by assessment of maximum plasma concentration (Cmax)
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Curve taken during each of the 5 treatments
10 secondary outcomes
Pharmacokinetics of AZD9291 and its metabolites by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of time to Cmax (tmax)
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of Terminal rate constant (λz)
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of Terminal half life (t1/2,λz)
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of lag time before observation of quantifiable analyte concentrations in plasma (tlag)
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of area under the plasma concentration-time curve from zero to time of last measurable concentration [AUC(0-t)]
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 and its metabolites, by assessment of area under the plasma concentration-time curve from zero to 72 hours [AUC(0-72)]
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 only, by assessment of apparent plasma clearance (CL/F).
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 only, apparent volume of distribution (Vz/F)
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Pharmacokinetics of AZD9291 parent to metabolite ratio (calculated for both Cmax and AUC).
Time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post 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 31 Mar 2017.
- D5160C00005revised\_csp\_2\_signed\_31March 16\_REDACTEDLink provided by the sponsor.
- D5160C00005\_CSR\_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.
Phil Leese, MD principal investigator
Quintiles 6700 W 115th Street, Kansas, US
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 AZD9291 in people with Healthy Volunteers, 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 1 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 31 Mar 2017. 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. 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?
Pharmacokinetics of AZD9291 and its metabolites, by assessment of maximum plasma concentration (Cmax) (time frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose). 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 31 Mar 2017.