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

Healthy Volunteers Clinical Trial

— AZD6244Formula  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635023
• Other study ID #: D1532C00066
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2012
• Last updated: October 24, 2012
• Start date: July 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD6244 Dosing Period 1
Treatment A, B, or C depending on randomization assignment
• AZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
• AZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
• AZD6244 Dosing Period 4
Treatment B

Locations

Country	Name	City	State
United States	Reseatch Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC for AZD6244 administered as a single dose of white (current Phase II) capsule formulation		Measured at appropriate time-points until end of treatment peiod, approximately 24 days	No
Primary	Cmax for AZD6244 administered as a ingle dose of white (current Phase II) capsule formulation		Measured at appropriate time-points until end of treatment peiod, approximately 24 days	No
Primary	AUC for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation		Measured at appropriate time-points until end of treatment peiod, approximately 24 days	No
Primary	Cmax for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation		Measured at appropriate time-points until end of treatment peiod, approximately 24 days	No
Secondary	Frequency and severity of adverse events		Measured throughout the study and for a7 days after the last dose, approximately 29 days	Yes
Secondary	AUC for AZD6244 administered as a single dose of oral solution formulation		Measured at appropriate time-points until end of treatment peiod, approximately 24 days	No
Secondary	Cmax for AZD6244 administered as a single dose of oral solution formulation		Measured at appropriate time-points until end of treatment peiod, approximately 24 days	No