AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy; Postmenopausal; Surgically Sterile Women

Treatments: Drug: AZD1981

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918398

D9831C00003

EudraCT No. 2009-010964-40

Details and patient eligibility

About

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

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

1

Experimental group

Description:

AZD1981, 100 mg iv infusion

Treatment:

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981

2

Experimental group

Description:

AZD1981, 514 mg oral solution

Treatment:

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981

3

Experimental group

Description:

AZD1981, 500 mg oral tablet A

Treatment:

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981

4

Experimental group

Description:

AZD1981, 500 mg oral tablet B

Treatment:

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981