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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Cmax,; Asthma,; Metabolite; λz,; Ketoconazole,; AUC,; Pharmacokinetics,; Tmax,

Treatments: Drug: AZD5069; Drug: Ketoconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01735240

D3550C00011

Details and patient eligibility

About

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).

Full 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

Enrollment: 15 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

First AZD5069, then Ketoconazole + AZD5069

Experimental group

Description:

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)

Treatment:

Drug: Ketoconazole

Drug: AZD5069