Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01635023
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: AZD6244 Dosing Period 1 Drug: AZD6244 Dosing Period 2 Drug: AZD6244 Dosing Period 3 Drug: AZD6244 Dosing Period 4 Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : July 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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 Name: AZD6244

Drug: AZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
Other Name: AZD6244

Drug: AZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
Other Name: 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 Name: AZD6244

Drug: AZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
Other Name: AZD6244

Drug: AZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
Other Name: AZD6244

Drug: AZD6244 Dosing Period 4
Treatment B
Other Name: AZD6244

Experimental: AZD6244 solution
35mg AZD6244 oral solution
Drug: AZD6244 Dosing Period 1
Treatment A, B, or C depending on randomization assignment
Other Name: AZD6244

Drug: AZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
Other Name: AZD6244

Drug: AZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
Other Name: AZD6244




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. Frequency and severity of adverse events [ Time Frame: Measured throughout the study and for a7 days after the last dose, approximately 29 days ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635023


Locations
Layout table for location information
United States, Kansas
Reseatch Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Study Director: Ian Smith, MEDICAL SCIENCE DIRECTOR AstraZeneca
Principal Investigator: Eleanor Lisbon, MD Quintiles, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01635023    
Other Study ID Numbers: D1532C00066
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: October 25, 2012
Last Verified: October 2012
Keywords provided by AstraZeneca:
Phase I
healthy volunteers
AZD6244
pharmacokinetics
AUC
Cmax
tmax
AUC(0-t)