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

NCT01635023 | Completed Phase 1

• 1 other identifier: D1532C00066
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (3)

AZD6244 white capsule

EXPERIMENTAL

75mg AZD6244 white (current Phase II) capsule

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

AZD6244 blue capsule

EXPERIMENTAL

75mg AZD6244 blue (planned Phase III) capsule

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

AZD6244 solution

EXPERIMENTAL

35mg AZD6244 oral solution

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

Interventions

AZD6244 Dosing Period 1 DRUG

Treatment A, B, or C depending on randomization assignment

Also known as: AZD6244

AZD6244 blue capsule; AZD6244 solution; AZD6244 white capsule

AZD6244 Dosing Period 2 DRUG

Treatment A, B, or C depending on randomization assignment

Also known as: AZD6244

AZD6244 blue capsule; AZD6244 solution; AZD6244 white capsule

AZD6244 Dosing Period 3 DRUG

Treatment A, B, or C depending on randomization assignment

Also known as: AZD6244

AZD6244 blue capsule; AZD6244 solution; AZD6244 white capsule

AZD6244 Dosing Period 4 DRUG

Treatment B

Also known as: AZD6244

AZD6244 blue capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Reseatch Site

Overland Park, Kansas, United States

Location

Related Publications (1)

• 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.

  PMID: 28985960 DERIVED

MeSH Terms

Interventions

AZD 6244

Study Officials

• Ian Smith, MEDICAL SCIENCE DIRECTOR

  AstraZeneca

  STUDY DIRECTOR

• Eleanor Lisbon, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: July 6, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

US (1)