NCT00707551

Brief Summary

The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

4 months

First QC Date

June 27, 2008

Last Update Submit

December 2, 2010

Conditions

Healthy

Keywords

AZD1305VerapamilKetoconazolepharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic variables

    During all dosing visits

Secondary Outcomes (1)

  • Adverse events, vital signs, ECG, laboratory variables and physical examination

    During the study

Study Arms (3)

1

EXPERIMENTAL

Ketoconazole tablet + AZD1305 Extended Release tablet

Drug: KetoconazoleDrug: AZD1305

2

EXPERIMENTAL

Verapamil Extended Release tablet + AZD1305 Extended Release tablet

Drug: VerapamilDrug: AZD1305

3

EXPERIMENTAL

AZD1305 Extended Release tablet

Drug: AZD1305

Interventions

KetoconazoleDRUG

Tablet, administered as repeated doses.

Also known as: Fungoral
1
VerapamilDRUG

Extended Release tablet, administered as repeated doses.

Also known as: Isoptin Retard
2
AZD1305DRUG

Extended Release tablet, administered as a single dose.

123

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

You may not qualify if:

  • Potassium outside normal reference values
  • ECG findings outside normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Berlin, Germany

Location

MeSH Terms

Interventions

KetoconazoleVerapamiltert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Helen Lunde, MD

    AstraZeneca R&D, Mölndal, Sweden

    STUDY DIRECTOR

  • Dago Mazur, MD, PhD

    PAREXEL International GmbH, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 1, 2008

Study Start

July 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

DE(1)