Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib
Phase 1
Completed
- Conditions
- Medullary Thyroid Cancer
- Interventions
- Registration Number
- NCT01539655
- Lead Sponsor
- Sanofi
- Brief Summary
Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib
- Detailed Description
A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of Vandetanib (CAPRELSA) in Healthy Subjects when a Single Oral Dose of Vandetanib 300 mg is Administered Alone and in Combination with Omeprazole or Ranitidine
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description vandetanib then vandetanib + ranitidine ranitidine Vandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2 vandetanib + ranitidine then vandetanib vandetanib Vandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2 vandetanib + ranitidine then vandetanib ranitidine Vandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2 vandetanib then vandetanib + omeprazole vandetanib Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2 vandetanib then vandetanib + omeprazole omeprazole Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2 vandetanib + omeprazole then vandetanib vandetanib Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2 vandetanib + omeprazole then vandetanib omeprazole Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2 vandetanib then vandetanib + ranitidine vandetanib Vandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2
- Primary Outcome Measures
Name Time Method Cmax for a single dose of vandetanib alone and in combination with omeprazole (PPI) Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose AUC(0-t) for a single dose of vandetanib alone and in combination with omeprazole (PPI) Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose Cmax for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist) Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose AUC(0-t) for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist) Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
- Secondary Outcome Measures
Name Time Method Other PK parameters for a single dose of vandetanib alone and in combination with omeprazole (PPI) Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose Other PK parameters for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist) Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose Frequency and severity of adverse events Treatment period + 7-14 days ECG data Treatment period + 7-14 days Laboratory data Treatment period + 7-14 days Vital signs data Treatment period + 7-14 days
Trial Locations
- Locations (1)
Research Site
🇺🇸Overland Park, Kansas, United States