A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 After Oral Single and Repeated Doses

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01199315

First received: September 9, 2010

Last updated: February 16, 2011

Last verified: February 2011

Purpose

The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446 in young and elderly healthy Japanese volunteers.

Condition	Intervention	Phase
Healthy	Drug: AZD1446 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
Official Title:	A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 in Young and Elderly Healthy Japanese Volunteers After Oral Single and Repeated Doses

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess safety and tolerability of AZD1446 following single and repeated doses of an orally administered MR capsule of AZD1446 in healthy young and elderly Japanese volunteers by adverse events, vital signs, laboratory variables and ECG. [ Time Frame: During the whole study period, ca. 50 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine PK of AZD1446 following single and repeated doses of AZD1446 MR capsule in healthy young and elderly Japanese volunteers. [ Time Frame: PK samplings are taken at defined timepoints during residential period, 10 days. ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	September 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Oral capsule. Dose single and followed by 5-day repeated dosing. Specific doses depend on panel.	Drug: AZD1446 oral capsule, Moderate Release
Placebo Comparator: 2 Oral capsule. Dose single and followed by 5-day repeated dosing.	Drug: Placebo oral capsule Other Name: Placebo

Eligibility

Criteria

Inclusion Criteria:

Healthy Japanese volunteers, aged ≥20 to ≤50 years for male young volunteers, ≥65 to ≤80 years for male or post-menopausal female elderly volunteers.
BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).

Exclusion Criteria:

History of severe allergy/hypersensitivity reactions including drug-allergy or drug hypersensitivity reactions, or ongoing allergy/hypersensitivity.
History or present symptoms or signs of Quincke oedema, angiooedema, or urticaria pigmentosa, or history of repeated episodes of urticaria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199315

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Björn Paulsson	AstraZeneca R&D Södertälje
Principal Investigator:	Shunji Matsuki, PhD	Kyushu Clinical Pharmacology Research Clinic

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01199315 History of Changes
Other Study ID Numbers:	D1950C00013
Study First Received:	September 9, 2010
Last Updated:	February 16, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

safety
tolerability
AZD1446

AD
ADHD
Japanese

ClinicalTrials.gov processed this record on May 23, 2013