NCT01092299

Brief Summary

Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different Extended/modified-release formulations and one immediate release formulation of AZD1446. In addition the food effect on AZD1446 pharmacokinetics will be investigated. Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in elderly healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2010

Typical duration for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 27, 2010

Status Verified

August 1, 2010

Enrollment Period

5 months

First QC Date

March 10, 2010

Last Update Submit

August 26, 2010

Conditions

Healthy

Keywords

Phase IRelative bioavailabilityPharmacokinetic studyAZD1446healthy volunteers

Outcome Measures

Primary Outcomes (2)

  • Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F

    Part 1 - 11 days

  • Part 2 Multiple Dose Administration: - Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F Day 9 of Part 2 following multiple dosing in addition to the above • Cmin, tmin, Cavg, fluctuation ratio, RCmax, RAUC(0-τ)

    Part 2 - 10 days

Secondary Outcomes (3)

  • Part 1: Safety and tolerabilty :- Laboratory safety data, vital signs, electrocardiogram, Columbia-Suicide Severity Rating Scale, adverse events, Mini-international neuropsychiatric interview

    throughout the approx 7 weeks of study duration

  • Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F

    Part 1 - 11 days

  • Part 2 Multiple Dose Administration :- Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F Day 9 of Part 2 following multiple dosing in addition to the above • Cmin, tmin, Cavg, fluctuation ratio, RCmax, RAUC(0-τ

    Part 2 - 10 days

Study Arms (6)

Cohort 1 (2 arms)

EXPERIMENTAL

Period 1: randomized to either fasting IR or ER1. Period 2: Cross-over to either IR or ER1. Period 3: ER1 in fed conditions.

Drug: AZD1446

Cohort 2 (2 arms)

EXPERIMENTAL

Period 1: randomized to either fasting IR or ER2. Period 2: Cross-over to either IR or ER2. Period 3: ER2 in fed conditions.

Drug: AZD1446

Cohort 3( 2 arms)

EXPERIMENTAL

Period 1: randomized to either fasting IR or ER3. Period 2: Cross-over to either IR or ER3. Period 3: ER3 in fed conditions.

Drug: AZD1446

Cohort 4 (2 arms)

EXPERIMENTAL

Period 1: randomized to either fasting IR or MR4. Period 2: Cross-over to either IR or MR4. Period 3: MR4 in fed conditions.

Drug: AZD1446

Part 2: Extended/Modified release

EXPERIMENTAL

Extended/Modified release capsule to be determined

Drug: AZD1446

Part 2: Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD1446DRUG

ER Fast, 90mg, p.o. capsule

Cohort 1 (2 arms)
PlaceboDRUG

IR

Part 2: Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • History or present symptoms or signs of severe allergy/hypersensitivity reactions including severe food allergy, as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Luleå, Sweden

Location

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

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

Study Officials

  • Lena Bolin

    AstraZeneca R&D

    STUDY DIRECTOR

  • Aslak Rautio

    Quintiles Hermelinen AB

    PRINCIPAL INVESTIGATOR

  • Wolfgang Kühn

    Quintiles AB, Phase I Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 24, 2010

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 27, 2010

Record last verified: 2010-08

Locations

SE(2)