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

NCT01457807 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-08-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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

DRUG

Placebo

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

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

Sponsors & Collaborators

Principal Investigators

  • Darren Wilbraham, MBBS, DCPSA · Quintiles drug research unit, 6 Newcomen Street, SE1 1YR

  • Bjorn Paulsson, MD, PHD · Astra Zeneca, Sodertalje, Sweden

  • Bo Fransson, MD, PHD · Astra Zeneca, Sodertalje, Sweden

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01457807 on ClinicalTrials.gov