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

Asthma, Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735240
• Other study ID #: D3550C00011
• Status: Completed
• Phase: Phase 1
• First received: November 20, 2012
• Last updated: June 24, 2015
• Start date: December 2012
• Est. completion date: February 2013

Study information

• Verified date: June 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• ?z,
• Asthma,
• AUC,
• Cmax,
• Ketoconazole,
• Metabolite
• Pharmacokinetics,
• Tmax,

Intervention

Drug:
• AZD5069
AZD5069 15 mg (3x5 mg capsules) single administration
• Ketoconazole
Ketoconazole 400 mg (2x200 mg tablets)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of AZD5069 (15 mg) and a metabolite (AZ13587715) measured by AUC, AUC(0-t), Cmax, ?z, t½?z, tmax, CL/F (AZD5069 only), Vz/F (alone and in combination with Ketoconazole)	(AUC(0-t)) area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, (Cmax) observed maximum plasma concentration, (?z) terminal rate constant, (t½?z) terminal half-life, (tmax) time to reach maximum plasma concentration (tmax), (CL/F) apparent oral clearance (AZD5069 only), (Vz/F) apparent volume of distribution.	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.	No
Primary	Pharmacokinetics of Ketoconazole measured by AUC(0-t) and Cmax (in combination with AZD5069)		Day 1, 2, 3 at 48 hours post dose and Day 4 at 72 post dose in period 2.	No
Secondary	Numbers of circulating neutrophil in blood measured by AZD5069 administration alone and in combination with Ketoconazole		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	Yes
Secondary	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.	Measures: laboratory assessments (clinical chemistry, haematology, urinalysis), vital signs (blood pressure, pulse rate, including body temperature), physical examination and 12-led electrocardiogram.	Up to 2 months	Yes

External Links

•   CSR Synopsis