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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT01539655

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Medullary Thyroid Cancer	Drug: vandetanib Drug: omeprazole Drug: ranitidine	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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 Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vandetanib then vandetanib + omeprazole Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2	Drug: vandetanib Oral tablets, 300 mg, single dose Drug: omeprazole Oral capsules, 40 mg, multiple doses
Experimental: vandetanib + omeprazole then vandetanib Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2	Drug: vandetanib Oral tablets, 300 mg, single dose Drug: omeprazole Oral capsules, 40 mg, multiple doses
Experimental: vandetanib then vandetanib + ranitidine Vandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2	Drug: vandetanib Oral tablets, 300 mg, single dose Drug: ranitidine Oral tables, 150 mg, multiple doses
Experimental: vandetanib + ranitidine then vandetanib Vandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2	Drug: vandetanib Oral tablets, 300 mg, single dose Drug: ranitidine Oral tables, 150 mg, multiple doses

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Frequency and severity of adverse events [Treatment period + 7-14 days]
ECG data [Treatment period + 7-14 days]
Laboratory data [Treatment period + 7-14 days]
Vital signs data [Treatment period + 7-14 days]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.