Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of Digoxin Administered Alone and in Combination With Vandetanib
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin administered alone and in combination with Vandetanib.
Key facts
- Study ID
- NCT01561781
- Run by
- Sanofi
- People needed
- 14
- Starts
- 2012-03-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2016-08-29
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Research Site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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