Medullary Thyroid Cancer
Conditions
Keywords
Phase 1, healthy volunteers, pharmacokinetics, vandetanib, omeprazole, ranitidine
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
Interventions
DRUGvandetanib
Oral tablets, 300 mg, single dose
DRUGomeprazole
Oral capsules, 40 mg, multiple doses
DRUGranitidine
Oral tables, 150 mg, multiple doses
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Frequency and severity of adverse events | Treatment period + 7-14 days |
| 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 |
| ECG data | Treatment period + 7-14 days |
| Laboratory data | Treatment period + 7-14 days |
| Vital signs data | Treatment period + 7-14 days |
Countries
United States
Outcome results
None listed