Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib
Completed · Phase 1
Conditions studied: Medullary Thyroid Cancer
In brief
Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib
Key facts
- Study ID
- NCT01539655
- Run by
- Sanofi
- People needed
- 34
- Starts
- 2012-02-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2017-05-02
Who can join
Age: 18 and older, up to 50. 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 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.
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 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
- 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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