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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01735240
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : June 25, 2015
Information provided by (Responsible Party):

Brief 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).

Condition or disease Intervention/treatment Phase
Asthma, Pharmacokinetics, Cmax, Tmax, λz, AUC, Ketoconazole, Metabolite Drug: AZD5069 Drug: Ketoconazole Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : December 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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)
Drug: AZD5069
AZD5069 15 mg (3x5 mg capsules) single administration

Drug: Ketoconazole
Ketoconazole 400 mg (2x200 mg tablets)

Primary Outcome Measures :
  1. Pharmacokinetics of AZD5069 (15 mg) and a metabolite (AZ13587715) measured by AUC, AUC(0-t), Cmax, λz, t½λz, tmax, CL/F (AZD5069 only), Vz/F (alone and in combination with Ketoconazole) [ Time Frame: Day 1, Day 2 at 24 hours post dose and Day 3 at 48 hours post dose in period 1 and Day 1, 2, 3 at 48 hours post dose and Day 4 at 72 post dose in period 2. ]
    (AUC(0-t)) area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, (Cmax) observed maximum plasma concentration, (λz) terminal rate constant, (t½λz) terminal half-life, (tmax) time to reach maximum plasma concentration (tmax), (CL/F) apparent oral clearance (AZD5069 only), (Vz/F) apparent volume of distribution.

  2. Pharmacokinetics of Ketoconazole measured by AUC(0-t) and Cmax (in combination with AZD5069) [ Time Frame: Day 1, 2, 3 at 48 hours post dose and Day 4 at 72 post dose in period 2. ]

Secondary Outcome Measures :
  1. Numbers of circulating neutrophil in blood measured by AZD5069 administration alone and in combination with Ketoconazole [ Time Frame: Day 1, 2, 3 at predose, 4, 8, 12, 24, 48 hours post dose in period 1 and Day 1, 2, 3, 4 at predose, 4, 8, 12, 24, 48 hours post dose ]
  2. Safety of AZD5069 (15 mg) in combination with Ketoconazole by assessing a panel of adverse events measures: laboratory assessments, vital signs, physical examination and 12-led electrocardiogram. [ Time Frame: Up to 2 months ]
    Measures: laboratory assessments (clinical chemistry, haematology, urinalysis), vital signs (blood pressure, pulse rate, including body temperature), physical examination and 12-led electrocardiogram.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01735240

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United Kingdom
London, United Kingdom
Sponsors and Collaborators
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Study Director: Bengt Larsson, Dr. AstraZeneca Pharmaceutical
Study Chair: Gillian Pilbrow AstraZeneca Pharmaceutical
Principal Investigator: Leonard Siew, DR. Quintiles Drug Research Unit at Guy's Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT01735240    
Other Study ID Numbers: D3550C00011
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015
Keywords provided by AstraZeneca:
Phase I,
healthy volunteers,
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors