AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations

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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Postmenopausal; Surgically Sterile Women
• Intervention / Treatment: Drug: AZD1981; Drug: AZD1981; Drug: AZD1981; Drug: AZD1981

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; AZD1981, 100 mg iv infusion	Drug: AZD1981; 100 mg iv infusion, single dose, 4 hours infusion; Drug: AZD1981; 514 mg oral solution, single dose; Drug: AZD1981; 500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose; Drug: AZD1981; 500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose
Experimental: 2; AZD1981, 514 mg oral solution	Drug: AZD1981; 100 mg iv infusion, single dose, 4 hours infusion; Drug: AZD1981; 514 mg oral solution, single dose; Drug: AZD1981; 500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose; Drug: AZD1981; 500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose
Experimental: 3; AZD1981, 500 mg oral tablet A	Drug: AZD1981; 100 mg iv infusion, single dose, 4 hours infusion; Drug: AZD1981; 514 mg oral solution, single dose; Drug: AZD1981; 500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose; Drug: AZD1981; 500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose
Experimental: 4; AZD1981, 500 mg oral tablet B	Drug: AZD1981; 100 mg iv infusion, single dose, 4 hours infusion; Drug: AZD1981; 514 mg oral solution, single dose; Drug: AZD1981; 500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose; Drug: AZD1981; 500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK samples for AZD1981 from both blood and urine	Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose.

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety variables (adverse events and laboratory safety lab)	Adverese events registered during study and vital signs and ECG at visit 1,2 ,6

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Eva Pettersson, AstraZeneca R&D, Lund, Sweden; Principal Investigator: Elisabeth Eden, Quintiles AB, Uppsala, Sweden

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Estimate): July 30, 2009
• Last Update Submitted That Met QC Criteria: July 29, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: D9831C00003; EudraCT No. 2009-010964-40