AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918398
• Other study ID #: D9831C00003
• Secondary ID: EudraCT No. 2009
• Status: Completed
• Phase: Phase 1
• First received: June 10, 2009
• Last updated: July 29, 2009
• Start date: June 2009
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Postmenopausal
• Surgically Sterile Women

Intervention

Drug:
• AZD1981
100 mg iv infusion, single dose, 4 hours infusion
• AZD1981
514 mg oral solution, single dose
• AZD1981
500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose
• AZD1981
500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Safety variables (adverse events and laboratory safety lab)		Adverese events registered during study and vital signs and ECG at visit 1,2 ,6	No