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A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination With a Single Dose of 800-mg Vandetanib (CAPRELSA)

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Conditions:		Healthy Volunteers
Purpose:		The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib.
Study Summary:		A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination with a Single Dose of 800-mg Vandetanib (CAPRELSA)
Criteria:		Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study - specific procedures: - Volunteers must be males or females aged 18 to 50 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2, inclusive - Females must have a negative pregnancy test at screening and on admission to the study center. - Females must not be lactating and must be of non-childbearing potential defined as postmenopausal or documentation of irreversible surgical sterilization. Exclusion Criteria: - History of any clinically significant disease or disorder such as gastrointestinal, hepatic, renal or skin disease. - History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, - Volunteers who smoke more than 5 cigarettes per day or are unable to refrain from smoking while resident in the study center - Screening blood pressure of greater than 140/90 mmHg and/or a resting heart rate of less than 45 beats per minute (repeat test allowed at the Investigator's discretion) - Clinically significant abnormal12-lead ECG as assessed by the Investigator, - QTcF interval greater than 450 ms - Any positive result on screening for: - serum hepatitis B surface antigen, - hepatitis C antibody, and - human immunodeficiency virus (HIV), or - Positive screen for drugs of abuse.
NCT ID:		NCT01544140
Primary Contact:		Study Director James Vasselli, SCIENCE DIR AstraZeneca
Backup Contact:		N/A
Location Contact:		Overland Park, Kansas United States There is no listed contact information for this specific location. Site Status: N/A

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