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

NCT01199315 | Completed Phase 1

• 1 other identifier: D1950C00013
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

safety; tolerability; AZD1446; AD; ADHD; Japanese

Outcome Measures

Primary Outcomes (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.

  During the whole study period, ca. 50 days

Secondary Outcomes (1)

• To determine PK of AZD1446 following single and repeated doses of AZD1446 MR capsule in healthy young and elderly Japanese volunteers.

  PK samplings are taken at defined timepoints during residential period, 10 days.

Study Arms (2)

1

EXPERIMENTAL

Oral capsule. Dose single and followed by 5-day repeated dosing. Specific doses depend on panel.

Drug: AZD1446

2

PLACEBO COMPARATOR

Oral capsule. Dose single and followed by 5-day repeated dosing.

Drug: Placebo

Interventions

AZD1446 DRUG

oral capsule, Moderate Release

1

Placebo DRUG

oral capsule

2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Fukuoka, Fukuoka, Japan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Björn Paulsson

  AstraZeneca R&D Södertälje

  STUDY DIRECTOR

• Shunji Matsuki, PhD

  Kyushu Clinical Pharmacology Research Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 17, 2011

Record last verified: 2011-02

Locations

JP (1)