A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244 (AZD6244Formula)

October 24, 2012 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States
        • Reseatch Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AZD6244 white capsule
75mg AZD6244 white (current Phase II) capsule
Drug: AZD6244 Dosing Period 1
Treatment A, B, or C depending on randomization assignment
Other Names:
  • AZD6244
Drug: AZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
Other Names:
  • AZD6244
Drug: AZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
Other Names:
  • AZD6244
EXPERIMENTAL: AZD6244 blue capsule
75mg AZD6244 blue (planned Phase III) capsule
Drug: AZD6244 Dosing Period 1
Treatment A, B, or C depending on randomization assignment
Other Names:
  • AZD6244
Drug: AZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
Other Names:
  • AZD6244
Drug: AZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
Other Names:
  • AZD6244
Drug: AZD6244 Dosing Period 4
Treatment B
Other Names:
  • AZD6244
EXPERIMENTAL: AZD6244 solution
35mg AZD6244 oral solution
Drug: AZD6244 Dosing Period 1
Treatment A, B, or C depending on randomization assignment
Other Names:
  • AZD6244
Drug: AZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
Other Names:
  • AZD6244
Drug: AZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
Other Names:
  • AZD6244

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Measured at appropriate time-points until end of treatment peiod, approximately 24 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency and severity of adverse events
Time Frame: Measured throughout the study and for a7 days after the last dose, approximately 29 days
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
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
Measured at appropriate time-points until end of treatment peiod, approximately 24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

July 3, 2012

First Posted (ESTIMATE)

July 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2012

Last Update Submitted That Met QC Criteria

October 24, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1532C00066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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