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

Medullary Thyroid Cancer Clinical Trial

— Vandetanib  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539655
• Other study ID #: D4200C00101
• Status: Completed
• Phase: Phase 1
• First received: February 10, 2012
• Last updated: April 28, 2017
• Start date: February 2012
• Est. completion date: September 2012

Study information

• Verified date: April 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Medullary Thyroid Cancer
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Frequency and severity of adverse events		Treatment period + 7-14 days
Secondary	ECG data		Treatment period + 7-14 days
Secondary	Laboratory data		Treatment period + 7-14 days
Secondary	Vital signs data		Treatment period + 7-14 days
Secondary	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
Secondary	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

External Links

•   Link
•   CSR-D4200C00101.pdf
•   Revised_CSP_redacted