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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 events

ECG 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

Page last updated: August 23, 2015

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