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: August 14, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Pharmacokinetic
Cmax
Tmax
Plasma AUC
Plasma [AUC(0-t)]
Plasma [AUC(0-672)]
(t1/2,λz)
Drug: vandetanib
Drug: omeprazole
Drug: ranitidine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: February 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539655

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: James Vasselli, MD AstraZeneca
Principal Investigator: Eleanor Lisbon, MD Quintiles
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01539655     History of Changes
Other Study ID Numbers: D4200C00101
Study First Received: February 10, 2012
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1
healthy volunteers
pharmacokinetics
vandetanib
omeprazole
ranitidine

Additional relevant MeSH terms:
Omeprazole
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014