Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetic; Cmax; Tmax; Plasma AUC; Plasma [AUC(0-t)]; Plasma [AUC(0-672)]; (t1/2,λz)
Intervention: vandetanib (Drug); omeprazole (Drug); ranitidine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): James Vasselli, MD, Study Director, Affiliation: AstraZeneca Eleanor Lisbon, MD, Principal Investigator, Affiliation: Quintiles
Summary
Study in healthy volunteers to assess effect of omeprazole and ranitidine on the
pharmacokinetics of vandetanib
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Cmax for a single dose of vandetanib alone and in combination with omeprazole (PPI)AUC(0-t) for a single dose of vandetanib alone and in combination with omeprazole (PPI) Cmax for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist) AUC(0-t) for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
Secondary outcome: Frequency and severity of adverse eventsECG data Laboratory data Vital signs data Other PK parameters for a single dose of vandetanib alone and in combination with omeprazole (PPI) Other PK parameters for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
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
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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 and Contacts
Research Site, Overland Park, Kansas, United States
Additional Information
CSR-D4200C00101.pdf Revised_CSP_redacted
Starting date: February 2012
Last updated: August 14, 2014
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