Pharmacokinetics
Conditions
Keywords
Formulation, pharmacokinetics
Brief summary
To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.
Interventions
DRUGAZD1386
One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Females must be non-fertile (Amenorrhea and no pregnancy in the last 12 months prior to enrolment or documentation of being irreversible surgically sterile). * Healthy male volunteers with BMI between 18 and 30 kg/m2 * Clinical normal physical findings, including blood pressure, pulse rate above 45 bpm, ECG, and laboratory assessments. * Normal QTc interval on baseline ECG, between 360-450 msec, according to the Fridericia formula.
Exclusion criteria
* History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity as judged by the Investigator. * Requirement of concomitant medication during the study, excluding hormone replacement therapy (HRT) or use of drugs with enzyme inducing properties with 3 weeks of first dose * Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before first administration of study drug * A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives and who have a QT/QTc \<360 ms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK variables | Frequent sampling occasions during study days |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables (adverse events, blood pressure, pulse, safety lab) | During the whole treatment period |
Outcome results
None listed