Clinical trial NCT01635023: A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Phase I
healthy volunteers
AZD6244
pharmacokinetics
AUC
Cmax
tmax
AUC(0-t)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: AUC for AZD6244 administered as a single dose of white (current Phase II) capsule formulation
timeFrame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
measure: Cmax for AZD6244 administered as a ingle dose of white (current Phase II) capsule formulation
timeFrame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
measure: AUC for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation
timeFrame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
measure: Cmax for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation
timeFrame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Secondary outcomes:
measure: Frequency and severity of adverse events
timeFrame: Measured throughout the study and for a7 days after the last dose, approximately 29 days
measure: AUC for AZD6244 administered as a single dose of oral solution formulation
timeFrame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
measure: Cmax for AZD6244 administered as a single dose of oral solution formulation
timeFrame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Reseatch Site
state: Kansas
Study officials:
affiliation: AstraZeneca
name: Ian Smith, MEDICAL SCIENCE DIRECTOR
role: STUDY_DIRECTOR
affiliation: Quintiles, Inc.
name: Eleanor Lisbon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.