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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AZD6244 Dosing Period 1; Drug: AZD6244 Dosing Period 2; Drug: AZD6244 Dosing Period 3; Drug: AZD6244 Dosing Period 4

• Registration Number: NCT01635023
• Lead Sponsor: AstraZeneca

Brief Summary

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 Timeline

• Study First Submitted: 2012-06-25
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-06
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-24
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AZD6244 white capsule	AZD6244 Dosing Period 1	75mg AZD6244 white (current Phase II) capsule
AZD6244 white capsule	AZD6244 Dosing Period 2	75mg AZD6244 white (current Phase II) capsule
AZD6244 white capsule	AZD6244 Dosing Period 3	75mg AZD6244 white (current Phase II) capsule
AZD6244 blue capsule	AZD6244 Dosing Period 1	75mg AZD6244 blue (planned Phase III) capsule
AZD6244 blue capsule	AZD6244 Dosing Period 2	75mg AZD6244 blue (planned Phase III) capsule
AZD6244 blue capsule	AZD6244 Dosing Period 3	75mg AZD6244 blue (planned Phase III) capsule
AZD6244 blue capsule	AZD6244 Dosing Period 4	75mg AZD6244 blue (planned Phase III) capsule
AZD6244 solution	AZD6244 Dosing Period 1	35mg AZD6244 oral solution
AZD6244 solution	AZD6244 Dosing Period 2	35mg AZD6244 oral solution
AZD6244 solution	AZD6244 Dosing Period 3	35mg AZD6244 oral solution

Primary Outcome Measures

Name	Time	Method
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events	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 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 at appropriate time-points until end of treatment peiod, approximately 24 days

Trial Locations

Locations (1)

Reseatch Site; 🇺🇸 Overland Park, Kansas, United States