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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Medullary Thyroid Cancer

Treatments: Drug: omeprazole; Drug: vandetanib; Drug: ranitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01539655

D4200C00101

Details and patient eligibility

About

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

Full 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

Enrollment: 34 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 4 patient groups

vandetanib then vandetanib + omeprazole

Experimental group

Description:

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

Treatment:

Drug: vandetanib

Drug: omeprazole

vandetanib + omeprazole then vandetanib

Experimental group

Description:

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

Treatment:

Drug: vandetanib

Drug: omeprazole

vandetanib then vandetanib + ranitidine

Experimental group

Description:

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

Treatment:

Drug: vandetanib

Drug: ranitidine

vandetanib + ranitidine then vandetanib

Experimental group

Description:

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

Treatment:

Drug: vandetanib

Drug: ranitidine