Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of Digoxin Administered Alone and in Combination With Vandetanib
Status: | |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any |
Updated: | 7/16/2012 |
Start Date: | March 2012 |
End Date: | June 2012 |
Contact: | AstraZeneca Clinical Study Information |
Email: | information.center@astrazeneca.com |
Phone: | 800-236-9933 |
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
This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin
administered alone and in combination with Vandetanib.
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
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.
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