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

NCT ID: NCT01635023

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Volunteers

Keywords

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Phase I healthy volunteers AZD6244 pharmacokinetics AUC Cmax tmax AUC(0-t)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AZD6244 white capsule

75mg AZD6244 white (current Phase II) capsule

Group Type EXPERIMENTAL

AZD6244 Dosing Period 1

Intervention Type DRUG

Treatment A, B, or C depending on randomization assignment

AZD6244 Dosing Period 2

Intervention Type DRUG

Treatment A, B, or C depending on randomization assignment

AZD6244 Dosing Period 3

Intervention Type DRUG

Treatment A, B, or C depending on randomization assignment

AZD6244 blue capsule

75mg AZD6244 blue (planned Phase III) capsule

Group Type EXPERIMENTAL

AZD6244 Dosing Period 1

Intervention Type DRUG

Treatment A, B, or C depending on randomization assignment

AZD6244 Dosing Period 2

Intervention Type DRUG

Treatment A, B, or C depending on randomization assignment

AZD6244 Dosing Period 3

Intervention Type DRUG

Treatment A, B, or C depending on randomization assignment

AZD6244 Dosing Period 4

Intervention Type DRUG

Treatment B

AZD6244 solution

35mg AZD6244 oral solution

Group Type EXPERIMENTAL

AZD6244 Dosing Period 1

Intervention Type DRUG

Treatment A, B, or C depending on randomization assignment

AZD6244 Dosing Period 2

Intervention Type DRUG

Treatment A, B, or C depending on randomization assignment

AZD6244 Dosing Period 3

Intervention Type DRUG

Treatment A, B, or C depending on randomization assignment

Interventions

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AZD6244 Dosing Period 1

Treatment A, B, or C depending on randomization assignment

Intervention Type DRUG

AZD6244 Dosing Period 2

Treatment A, B, or C depending on randomization assignment

Intervention Type DRUG

AZD6244 Dosing Period 3

Treatment A, B, or C depending on randomization assignment

Intervention Type DRUG

AZD6244 Dosing Period 4

Treatment B

Intervention Type DRUG

Other Intervention Names

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AZD6244 AZD6244 AZD6244 AZD6244

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian Smith, MEDICAL SCIENCE DIRECTOR

Role: STUDY_DIRECTOR

AstraZeneca

Eleanor Lisbon, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Reseatch Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

References

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Tomkinson H, McBride E, Martin P, Lisbon E, Dymond AW, Cantarini M, So K, Holt D. Comparison of the Pharmacokinetics of the Phase II and Phase III Capsule Formulations of Selumetinib and the Effects of Food on Exposure: Results From Two Randomized Crossover Trials in Healthy Male Subjects. Clin Ther. 2017 Nov;39(11):2260-2275.e1. doi: 10.1016/j.clinthera.2017.08.022. Epub 2017 Oct 4.

Reference Type DERIVED
PMID: 28985960 (View on PubMed)

Other Identifiers

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D1532C00066

Identifier Type: -

Identifier Source: org_study_id