Status:
COMPLETED
Formulation and Food Effect Study of AZD1386 in Healthy Volunteers
Lead Sponsor:
AstraZeneca
Conditions:
Pharmacokinetics
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00714337
Start Date
June 1 2008
End Date
August 1 2008
Last Update
December 10 2010
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