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Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib

NCT01539655

CompletedPhase 1

Sponsor: Sanofi

Conditions: Medullary Thyroid Cancer

Interventions: vandetanib, omeprazole, ranitidine

Countries: United States

Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib

Eligibility overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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
* Human immunodeficiency virus (HIV), or positive screen for drugs of abuse.

Locations (1)

Overland Park, Kansas, United States