NCT01735240

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

An Open-label, Fixed-sequence, Single-centre Phase I Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of AZD5069 After Oral Administration of a Single Dose AZD5069 to Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed description

An open-label, fixed-sequence, single-centre phase I study to assess the effect of ketoconazole on the pharmacokinetics of AZD5069 after oral administration of a single dose AZD5069 to healthy male volunteers

Conditions

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

Interventions

Type	Name	Description
DRUG	AZD5069	AZD5069 15 mg (3x5 mg capsules) single administration
DRUG	Ketoconazole	Ketoconazole 400 mg (2x200 mg tablets)

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-11-28
• Last updated: 2015-06-25

Locations

1 site across 1 country: United Kingdom