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

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ClinicalTrials.gov Identifier: NCT01199315
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD1446 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01199315     History of Changes
Other Study ID Numbers: D1950C00013
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: February 2011

Keywords provided by AstraZeneca:
safety
tolerability
AZD1446
AD
ADHD
Japanese