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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-02-28

Brief Summary

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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).

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Detailed Description

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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

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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First AZD5069, then Ketoconazole + AZD5069

AZD5069 in first period (on 1 day) and in second period (after wash out) ketoconazole alone (on 2 days) then ketoconazole + AZD5069 (on 1 day), then again ketoconazole alone (on 2 days)

Group Type EXPERIMENTAL

AZD5069

Intervention Type DRUG

AZD5069 15 mg (3x5 mg capsules) single administration

Ketoconazole

Intervention Type DRUG

Ketoconazole 400 mg (2x200 mg tablets)

Interventions

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AZD5069

AZD5069 15 mg (3x5 mg capsules) single administration

Intervention Type DRUG

Ketoconazole

Ketoconazole 400 mg (2x200 mg tablets)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers aged 18 to 50 years (inclusive).
* Veins suitable for cannulation or repeated venipuncture.
* Healthy volunteers with neutrophil counts within the laboratory normal reference range at Screening
* Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum weight 50 kg and maximum weight 100 kg.
* Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening and a smoking history of less than 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for 1 year) at screening.

Exclusion Criteria

* Healthy volunteers with latent tuberculosis as suggested by their history and judged by the Investigator
* Healthy volunteers who belong to a high-risk group for HIV infection.
* Known or suspected history of significant drug abuse as judged by the Investigator.
* History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.
* Plasma donation within 1 month of screening or any blood donation/blood loss \>500 mL during the 3 months and/or 1350 mL within the 12 months prior to screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes