An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

A Phase I, Single-centre, Randomised, Open, Three-way Crossover Study to Evaluate the Effect of Ketoconazole and Verapamil, Respectively, on the Pharmacokinetics of AZD1305 After Repeated Oral Adm of Ketoconazole and Verapamil and Single Oral Dosing of AZD1305 to Young Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00707551

Enrollment

Registered

2008-07-01

Start date

2008-07-31

Completion date

2008-11-30

Last updated

2010-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

AZD1305, Verapamil, Ketoconazole, pharmacokinetics

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.

Interventions

DRUGKetoconazole

Tablet, administered as repeated doses.

DRUGVerapamil

Extended Release tablet, administered as repeated doses.

DRUGAZD1305

Extended Release tablet, administered as a single dose.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic variables	During all dosing visits

Secondary

Measure	Time frame
Adverse events, vital signs, ECG, laboratory variables and physical examination	During the study

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026