Healthy VolunteersPhase 1AZD6244FormulaNCT01635023
A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244
A Phase 1 study testing AZD6244 Dosing Period 1, AZD6244 Dosing Period 2 and AZD6244 Dosing Period 3 in people with Healthy Volunteers, run by AstraZeneca at 1 site in United States.
Trial summary
Study in Healthy Males to Compare the White and Blue Formulations of AZD6244. 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?
- AZD6244 Dosing Period 1, AZD6244 Dosing Period 2 and AZD6244 Dosing Period 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2012
- 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
- Healthy male volunteers aged 18 to 55 BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive Calculated creatinine clearance (CRCL) greater than 50 mL/min usin gthe Cockcroft-Gault formula
Who cannot join
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition know to interfere with absorption, distribution, metabolism, or exertion of drugs.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting dECG and any clinically important abnormalities in the 12-lead dECG that suggest a cardiac, metabolic or other noncardiac condition.
- Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma Known or suspected history of drug abuse, current smokes or those who have smoked or used nicotine-containing products within the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate in Healthy Male Subjects
Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.
Read the detailed description
A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate in Healthy Male Subjects.
- Conditions
- Healthy Volunteers
- Being tested
- AZD6244 Dosing Period 1, AZD6244 Dosing Period 2, AZD6244 Dosing Period 3, AZD6244 Dosing Period 4
- Keywords
- Phase I, healthy volunteers, AZD6244, pharmacokinetics, AUC, Cmax, tmax, AUC(0-t)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6244 Dosing Period 1Drug
Also called AZD6244
Treatment A, B, or C depending on randomization assignment
AZD6244 Dosing Period 2Drug
Also called AZD6244
Treatment A, B, or C depending on randomization assignment
AZD6244 Dosing Period 3Drug
Also called AZD6244
Treatment A, B, or C depending on randomization assignment
AZD6244 Dosing Period 4Drug
Also called AZD6244
Treatment B
| Study group | Role | What they receive |
|---|---|---|
| AZD6244 white capsule | Experimental | 75mg AZD6244 white (current Phase II) capsule Receives: Drug: AZD6244 Dosing Period 1; Drug: AZD6244 Dosing Period 2; Drug: AZD6244 Dosing Period 3 |
| AZD6244 blue capsule | Experimental | 75mg AZD6244 blue (planned Phase III) capsule Receives: Drug: AZD6244 Dosing Period 1; Drug: AZD6244 Dosing Period 2; Drug: AZD6244 Dosing Period 3; Drug: AZD6244 Dosing Period 4 |
| AZD6244 solution | Experimental | 35mg AZD6244 oral solution Receives: Drug: AZD6244 Dosing Period 1; Drug: AZD6244 Dosing Period 2; Drug: AZD6244 Dosing Period 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC for AZD6244 administered as a single dose of white (current Phase II) capsule formulation
Measured: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a ingle dose of white (current Phase II) capsule formulation
Measured: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
AUC for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation
Measured: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation
Measured: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Secondary outcomes (3)
Frequency and severity of adverse events
Measured: Measured throughout the study and for a7 days after the last dose, approximately 29 days
AUC for AZD6244 administered as a single dose of oral solution formulation
Measured: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a single dose of oral solution formulation
Measured: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian Smith, MEDICAL SCIENCE DIRECTOR, Study director, AstraZenecaEleanor Lisbon, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635023
- Sponsor's protocol ID
- D1532C00066
- Acronym
- AZD6244Formula
- Status last verified
- Oct 2012
- First submitted
- 25 Jun 2012
- Last updated
- 25 Oct 2012
- Results posted
- No
Publications
Tomkinson H, McBride E, Martin P, Lisbon E, Dymond AW, Cantarini M, So K, Holt D. Comparison of the Pharmacokinetics of the Phase II and Phase III Capsule Formulations of Selumetinib and the Effects of Food on Exposure: Results From Two Randomized Crossover Trials in Healthy Male Subjects. Clin Ther. 2017 Nov;39(11):2260-2275.e1. doi: 10.1016/j.clinthera.2017.08.022. Epub 2017 Oct 4.
PubMed 28985960
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01635023
- Acronym / sponsor ID
- AZD6244Formula / D1532C00066
- Conditions
- Healthy Volunteers
- Keywords
- Phase I, healthy volunteers, AZD6244, pharmacokinetics, AUC, Cmax, tmax, AUC(0-t)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Jul 2012 (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.
Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.
Detailed description
A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate in Healthy Male Subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZD6244 white capsule | Experimental | Drug: AZD6244 Dosing Period 1, Drug: AZD6244 Dosing Period 2, Drug: AZD6244 Dosing Period 375mg AZD6244 white (current Phase II) capsule |
| AZD6244 blue capsule | Experimental | Drug: AZD6244 Dosing Period 1, Drug: AZD6244 Dosing Period 2, Drug: AZD6244 Dosing Period 3, Drug: AZD6244 Dosing Period 475mg AZD6244 blue (planned Phase III) capsule |
| AZD6244 solution | Experimental | Drug: AZD6244 Dosing Period 1, Drug: AZD6244 Dosing Period 2, Drug: AZD6244 Dosing Period 335mg AZD6244 oral solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteers aged 18 to 55 BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive Calculated creatinine clearance (CRCL) greater than 50 mL/min usin gthe Cockcroft-Gault formula
Key exclusion criteria (4 listed)
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition know to interfere with absorption, distribution, metabolism, or exertion of drugs.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting dECG and any clinically important abnormalities in the 12-lead dECG that suggest a cardiac, metabolic or other noncardiac condition.
- Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma Known or suspected history of drug abuse, current smokes or those who have smoked or used nicotine-containing products within the previous 3 months
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 |
|---|---|---|
| AZD6244 Dosing Period 1Also: AZD6244Treatment A, B, or C depending on randomization assignment | Drug | AZD6244 blue capsule, AZD6244 solution, AZD6244 white capsule |
| AZD6244 Dosing Period 2Also: AZD6244Treatment A, B, or C depending on randomization assignment | Drug | AZD6244 blue capsule, AZD6244 solution, AZD6244 white capsule |
| AZD6244 Dosing Period 3Also: AZD6244Treatment A, B, or C depending on randomization assignment | Drug | AZD6244 blue capsule, AZD6244 solution, AZD6244 white capsule |
| AZD6244 Dosing Period 4Also: AZD6244Treatment B | Drug | AZD6244 blue capsule |
Primary outcome
AUC for AZD6244 administered as a single dose of white (current Phase II) capsule formulation
Time frame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a ingle dose of white (current Phase II) capsule formulation
Time frame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
AUC for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation
Time frame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation
Time frame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
3 secondary outcomes
Frequency and severity of adverse events
Time frame: Measured throughout the study and for a7 days after the last dose, approximately 29 days
AUC for AZD6244 administered as a single dose of oral solution formulation
Time frame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a single dose of oral solution formulation
Time frame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
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 25 Oct 2012.
- Derived from this study: PubMed 28985960Tomkinson H, McBride E, Martin P, Lisbon E, Dymond AW, Cantarini M, So K, Holt D. Comparison of the Pharmacokinetics of the Phase II and Phase III Capsule Formulations of Selumetinib and the Effects of Food on Exposure: Results From Two Randomized Crossover Trials in Healthy Male Subjects. Clin Ther. 2017 Nov;39(11):2260-2275.e1. doi: 10.1016/j.clinthera.2017.08.022. Epub 2017 Oct 4.
Related trials for Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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.
Ian Smith, MEDICAL SCIENCE DIRECTOR study director
AstraZeneca
Eleanor Lisbon, MD 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 AZD6244 Dosing Period 1, AZD6244 Dosing Period 2 and AZD6244 Dosing Period 3 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 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 25 Oct 2012. 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?
AUC for AZD6244 administered as a single dose of white (current Phase II) capsule formulation (time frame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635023, which also lists 1 linked publication.
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 25 Oct 2012.