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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-09-30

Brief Summary

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Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib

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Detailed Description

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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

Conditions

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Medullary Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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vandetanib then vandetanib + omeprazole

Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2

Group Type EXPERIMENTAL

vandetanib

Intervention Type DRUG

Oral tablets, 300 mg, single dose

omeprazole

Intervention Type DRUG

Oral capsules, 40 mg, multiple doses

vandetanib + omeprazole then vandetanib

Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2

Group Type EXPERIMENTAL

vandetanib

Intervention Type DRUG

Oral tablets, 300 mg, single dose

omeprazole

Intervention Type DRUG

Oral capsules, 40 mg, multiple doses

vandetanib then vandetanib + ranitidine

Vandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2

Group Type EXPERIMENTAL

vandetanib

Intervention Type DRUG

Oral tablets, 300 mg, single dose

ranitidine

Intervention Type DRUG

Oral tables, 150 mg, multiple doses

vandetanib + ranitidine then vandetanib

Vandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2

Group Type EXPERIMENTAL

vandetanib

Intervention Type DRUG

Oral tablets, 300 mg, single dose

ranitidine

Intervention Type DRUG

Oral tables, 150 mg, multiple doses

Interventions

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vandetanib

Oral tablets, 300 mg, single dose

Intervention Type DRUG

omeprazole

Oral capsules, 40 mg, multiple doses

Intervention Type DRUG

ranitidine

Oral tables, 150 mg, multiple doses

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes