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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01539655

First received: February 10, 2012

Last updated: September 28, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 10, 2012

Last Updated Date

September 28, 2012

Start Date ^ICMJE

February 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cmax for a single dose of vandetanib alone and in combination with omeprazole (PPI) [ Time Frame: 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 ] [ Designated as safety issue: No ]
AUC(0-t) for a single dose of vandetanib alone and in combination with omeprazole (PPI) [ Time Frame: 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 ] [ Designated as safety issue: No ]
Cmax for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist) [ Time Frame: 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 ] [ Designated as safety issue: No ]
AUC(0-t) for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01539655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Frequency and severity of adverse events [ Time Frame: Treatment period + 7-14 days ] [ Designated as safety issue: Yes ]
ECG data [ Time Frame: Treatment period + 7-14 days ] [ Designated as safety issue: Yes ]
Laboratory data [ Time Frame: Treatment period + 7-14 days ] [ Designated as safety issue: Yes ]
Vital signs data [ Time Frame: Treatment period + 7-14 days ] [ Designated as safety issue: Yes ]
Other PK parameters for a single dose of vandetanib alone and in combination with omeprazole (PPI) [ Time Frame: 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 ] [ Designated as safety issue: No ]
Other PK parameters for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Pharmacokinetic
Cmax
Tmax
Plasma AUC
Plasma [AUC(0-t)]
Plasma [AUC(0-672)]
(t1/2,λz)

Intervention ^ICMJE

Drug: vandetanib
Oral tablets, 300 mg, single dose
Drug: omeprazole
Oral capsules, 40 mg, multiple doses
Drug: ranitidine
Oral tables, 150 mg, multiple doses

Study Arm (s)

Experimental: vandetanib then vandetanib + omeprazole
Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2
Interventions:
- Drug: vandetanib
- Drug: omeprazole
Experimental: vandetanib + omeprazole then vandetanib
Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2
Interventions:
- Drug: vandetanib
- Drug: omeprazole
Experimental: vandetanib then vandetanib + ranitidine
Vandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2
Interventions:
- Drug: vandetanib
- Drug: ranitidine
Experimental: vandetanib + ranitidine then vandetanib
Vandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2
Interventions:
- Drug: vandetanib
- Drug: ranitidine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01539655

Other Study ID Numbers ^ICMJE

D4200C00101

Has Data Monitoring Committee

Not Provided

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	James Vasselli, MD	AstraZeneca
Principal Investigator:	Eleanor Lisbon, MD	Quintiles

Information Provided By

AstraZeneca

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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