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A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With a Single Dose of Vandetanib (CAPRELSA) 300 mg

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Conditions:		Healthy Volunteers
Purpose:		This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin administered alone and in combination with Vandetanib.
Study Summary:		A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination with a Single Dose of Vandetanib (CAPRELSA) 300 mg
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 45 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 are current smokers and have smoked or used nicotine products within the previous 6 months - 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:		NCT01561781
Primary Contact:		Study Director James Vasselli, MSD 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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