Formulation and Food Effect Study of AZD1386 in Healthy Volunteers

Pharmacokinetics Clinical Trial

Official title:

A Phase I, Single-Centre, Randomised, Open-Label, Five-Way Cross-Over Formulation- and Food-Effect Study in Healthy Volunteers to Assess the Pharmacokinetics of AZD1386 After Single Doses of Two Oral Solid Formulations and an Oral Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714337
• Other study ID #: D5090C00007
• Secondary ID: EudraCT 2008-002
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2008
• Last updated: December 8, 2010
• Start date: June 2008
• Est. completion date: August 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• AZD1386
One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).
• AZD1386
One single oral dose of 90mg (3 x 30mg AZD1386 capsules)
• AZD1386
One single oral dose of 90mg (6 x 15mg AZD1386 tablets)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Frequent sampling occasions during study days	No
Secondary	Safety variables (adverse events, blood pressure, pulse, safety lab)		During the whole treatment period	Yes