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Completed

NCT Number: NCT01635023

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

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

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Reseatch Site

Overland Park, Kansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6244 Dosing Period 1

Drug

Treatment A, B, or C depending on randomization assignment

Other names: AZD6244

AZD6244 Dosing Period 2

Drug

Treatment A, B, or C depending on randomization assignment

Other names: AZD6244

AZD6244 Dosing Period 3

Drug

Treatment A, B, or C depending on randomization assignment

Other names: AZD6244

AZD6244 Dosing Period 4

Drug

Treatment B

Other names: AZD6244

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: AZD6244Formula

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 6, 2012
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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