Healthy Volunteers
Conditions
Keywords
Phase I, healthy volunteers, AZD6244, pharmacokinetics, AUC, Cmax, tmax, AUC(0-t)
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.
Interventions
DRUGAZD6244 Dosing Period 1
Treatment A, B, or C depending on randomization assignment
DRUGAZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
DRUGAZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
DRUGAZD6244 Dosing Period 4
Treatment B
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Frequency and severity of adverse events | Measured throughout the study and for a7 days after the last dose, approximately 29 days |
Countries
United States
Outcome results
None listed