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To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers

NCT ID: NCT01457807

Last Updated: 2012-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2011-12-31

Brief Summary

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To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new, different extended release formulations of tablets of AZD3241 (300 mg), in relation to the 100 mg extended release tablet used in a previous study and potential food interaction. The safety and tolerability of AZD 3241 will also be investigated as a secondary objective. In addition to these a number of exploratory objectives will be investigated with blood sampling.

Detailed Description

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A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) after Administration of Multiple Doses in Healthy Male and Female Volunteers

Conditions

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Parkinson's Disease

Keywords

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Phase 1 Parkinson's disease pharmacodynamic biomarkers pharmacokinetics extended release formulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

AZD3241 300mg extended release formulation 1

Group Type EXPERIMENTAL

AZD3241 ER formulation 1

Intervention Type DRUG

Oral tablets, 100mg bd on Day 1 to Day 2, 200mg bd on Day3, 300mg bd on Day 4 to Day7 and 300mg Once daily on Day 8 with High Fat Breakfast

AZD3241 Alternative titration scheme with formulation 1 or 2

Intervention Type DRUG

50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8

2

AZD3241 300mg extended release formulation 2

Group Type EXPERIMENTAL

AZD3241 Alternative titration scheme with formulation 1 or 2

Intervention Type DRUG

50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered with the same intervention scheme as intervention 1 and 2

Interventions

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AZD3241 ER formulation 1

Oral tablets, 100mg bd on Day 1 to Day 2, 200mg bd on Day3, 300mg bd on Day 4 to Day7 and 300mg Once daily on Day 8 with High Fat Breakfast

Intervention Type DRUG

Placebo

Placebo will be administered with the same intervention scheme as intervention 1 and 2

Intervention Type DRUG

AZD3241 Alternative titration scheme with formulation 1 or 2

50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8

Intervention Type DRUG

Other Intervention Names

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This titration scheme will only be used if ER formulations 1 or 2 are not well tolerated

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male or female volunteers aged 30 to 65 years, inclusive, with suitable veins for cannulation or repeated venepuncture
* Female volunteers must have a negative pregnancy test at Screening and on admission to the CPU, must not be lactating and must be of non childbearing potential, confirmed at Screening
* Male volunteers must be willing to use barrier contraception ie, condoms, from the first day of dose administration until 3 months after the last dose of the IP
* Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria

* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3241
* Orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg decrease in diastolic BP as measured at enrolment and/or randomisation
* History of intolerance or hypersensitivity to mannitol
* Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF)\>450 ms or shortened QTcF\<340 ms or a family history of long QT syndrome
* Abnormal vital signs, after 10 minutes of rest in supine position, defined as any of the following:Systolic BP\>140 mmHg., Diastolic BP\>90 mmHg., Heart rate\<40 or \>85 beats per minute.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darren Wilbraham, MBBS, DCPSA

Role: PRINCIPAL_INVESTIGATOR

Quintiles drug research unit, 6 Newcomen Street, SE1 1YR

Bjorn Paulsson, MD, PHD

Role: STUDY_DIRECTOR

Astra Zeneca, Sodertalje, Sweden

Bo Fransson, MD, PHD

Role: STUDY_CHAIR

Astra Zeneca, Sodertalje, Sweden

Locations

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Research site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D0490C00003

Identifier Type: -

Identifier Source: org_study_id