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Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.

NCT01735240 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-06-25

No results posted yet for this study

Summary

The main purpose of the study is to compare the change of the AZD5069 Pharmacokinetic profile when administered with ketoconazole. Subjects will be treated first with AZD5069 only followed by a washout period before starting with the combined treatment (both ketoconazole and AZD5069).

Conditions

  • Asthma,
  • Pharmacokinetics,
  • Cmax,
  • Tmax,
  • λz,
  • AUC,
  • Ketoconazole,
  • Metabolite

Interventions

DRUG

AZD5069

AZD5069 15 mg (3x5 mg capsules) single administration

DRUG

Ketoconazole

Ketoconazole 400 mg (2x200 mg tablets)

Sponsors & Collaborators

Principal Investigators

  • Bengt Larsson, Dr. · AstraZeneca Pharmaceutical

  • Gillian Pilbrow · AstraZeneca Pharmaceutical

  • Leonard Siew, DR. · Quintiles Drug Research Unit at Guy's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT01735240 on ClinicalTrials.gov