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Completed

NCT Number: NCT00918398

AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations

The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance

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Key information

Conditions

Healthy Postmenopausal Surgically Sterile Women

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of informed consent prior to any study specific procedures
  • Men or post-menopausal or surgically sterile women, aged 18 to 55 years
  • Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1 (pre-entry)

Exclusion criteria

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
  • Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study

Treatment and study plan

AZD1981

Drug

100 mg iv infusion, single dose, 4 hours infusion

Primary outcomes

  1. PK samples for AZD1981 from both blood and urine

    Time frame: Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose.

Secondary outcomes

  1. Safety variables (adverse events and laboratory safety lab)

    Time frame: Adverese events registered during study and vital signs and ECG at visit 1,2 ,6

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open, Single-dose, Phase I, 4-period Partly Crossover Study in Healthy Men or Women to Assess Relative Bioavailability of Oral Administration of AZD1981 Via Tablets Compared With Suspension and Basic Systemic Pharmacokinetic Parameters After Intravenous Administration

Important dates

Study start
2009
Study completion
2009
First posted
Jun 11, 2009
Registry last updated
Jul 30, 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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