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Completed

NCT Number: NCT00799331

Exploratory Study to Assess the Pharmacokinetics of AZD5985

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD5985

Drug

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.

Placebo

Drug

Oral suspension.

Primary outcomes

  1. 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.

    Time frame: Frequent sampling occasions during study days

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 27, 2008
Registry last updated
Jun 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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