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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AZD6244 Dosing Period 2; Drug: AZD6244 Dosing Period 4; Drug: AZD6244 Dosing Period 1; Drug: AZD6244 Dosing Period 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT01635023

D1532C00066

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

AZD6244 white capsule

Experimental group

Description:

75mg AZD6244 white (current Phase II) capsule

Treatment:

Drug: AZD6244 Dosing Period 3

Drug: AZD6244 Dosing Period 1

Drug: AZD6244 Dosing Period 2

AZD6244 blue capsule

Experimental group

Description:

75mg AZD6244 blue (planned Phase III) capsule

Treatment:

Drug: AZD6244 Dosing Period 3

Drug: AZD6244 Dosing Period 1

Drug: AZD6244 Dosing Period 4

Drug: AZD6244 Dosing Period 2

AZD6244 solution

Experimental group

Description:

35mg AZD6244 oral solution

Treatment:

Drug: AZD6244 Dosing Period 3

Drug: AZD6244 Dosing Period 1

Drug: AZD6244 Dosing Period 2