Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446

NCT00902993 | Completed Phase 1

• 2 other identifiers: D1950C00002EudraCT No. 2008-008389-10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6 multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.

Conditions

Healthy

Keywords

MAD; NNR; to investigate safety and tolerability in a multiple ascending dose study in Healthy subjects; AZD1446

Outcome Measures

Primary Outcomes (2)

• Part A: to assess the safety and tolerability of AZD1446 following multiple ascending doses of an orally administered solution of AZD1446 in male and non-fertile female, young and elderly Healthy Volunteers,

  during the whole study period, ca 50 days

• Part B: to assess the safety and tolerability of AZD1446 following administration of an oral solution of AZD1446 as fractionated doses during one day in male and non-fertile female, young and elderly Healthy Volunteers.

  during the whole study period, ca 43 days

Secondary Outcomes (2)

• Part A: To determine the single and multiple dose PK of AZD1446 in male and non-fertile female Healthy Volunteers.

  PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B

• Part B: To mimic an extended release dosing regimen and determine the fractionated dosing PK of AZD1446 in male and non-fertile Healthy Volunteers.

  PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B

Study Arms (2)

1

EXPERIMENTAL

Part A single and multiple dose and part B fractionated dose

Drug: AZD1446

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD1446 DRUG

Solution, oral single and multiple dose

1

Placebo DRUG

Placebo

2

Eligibility Criteria

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

You may qualify if:

• Male or non-fertile female, young or elderly Subjects, aged ≥18 to ≤50 or ≥65 to ≤80
• Body mass index (BMI) between 19 and 30 kg/m2
• Clinically normal findings on physical examination

You may not qualify if:

• History of any clinically significant disease or disorder
• History of severe allergy/hypersensitivity reactions

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Gothenburg, Sweden

Location

Research Site

Stockholm, Sweden

Location

MeSH Terms

Interventions

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

Study Officials

• Björn Paulsson, MD, PhD

  AstraZeneca

  STUDY DIRECTOR

• Marianne Hartford, MD PhD

  AstraZeneca Clinical Pharmacology Unit (CPU) Sahlgrenska University Hospital GöteborgSE-413 45 GöteborgSweden

  PRINCIPAL INVESTIGATOR

• Ingemar Bylesjo, MD PhD

  AstraZeneca Clinical Pharmacology Unit (CPU) C2:84Karolinska University Hospital HuddingeSE-141 86 StockholmSweden

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 15, 2009
• Study Start: April 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 1, 2009

Record last verified: 2009-09

Locations

SE (2)