Exploratory Study to Assess the Pharmacokinetics of AZD5985

An Exploratory Phase I, Single Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study to Assess the Pharmacokinetics of Increasing Oral Doses of AZD5985 in Healthy Male Volunteers

The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD5985; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Provision of signed, written and dated informed consent prior to any study specific procedures.
• Healthy male subjects aged 18 to 45 years (inclusive).
• Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
• Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.

Exclusion Criteria:

• History or presence of any clinically significant disease or disorder in the opinion of the investigator.
• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
• Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; AZD5985	Drug: AZD5985; Oral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits.
Experimental: B; placebo	Drug: placebo; Oral suspension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985.	Frequent sampling occasions during study days

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Eva Pettersson, AstraZeneca R&D, Lund, Sweden; Principal Investigator: Maura Fallon, Parexel, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: November 21, 2008
• First Submitted That Met QC Criteria: November 26, 2008
• First Posted (Estimate): November 27, 2008

Study Record Updates

• Last Update Posted (Estimate): June 9, 2009
• Last Update Submitted That Met QC Criteria: June 8, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Other Study ID Numbers: D2300C00001; EudraCt No. 2008-005121-11