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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Research Site
Fukuoka, Japan
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 September 16, 2014