NCT01539655

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

February 10, 2012

Last Update Submit

April 28, 2017

Conditions

Medullary Thyroid Cancer

Keywords

Phase 1healthy volunteerspharmacokineticsvandetanibomeprazoleranitidine

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (4)

vandetanib then vandetanib + omeprazole

EXPERIMENTAL

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

Drug: vandetanibDrug: omeprazole

vandetanib + omeprazole then vandetanib

EXPERIMENTAL

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

Drug: vandetanibDrug: omeprazole

vandetanib then vandetanib + ranitidine

EXPERIMENTAL

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

Drug: vandetanibDrug: ranitidine

vandetanib + ranitidine then vandetanib

EXPERIMENTAL

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

Drug: vandetanibDrug: ranitidine

Interventions

vandetanibDRUG

Oral tablets, 300 mg, single dose

vandetanib + omeprazole then vandetanibvandetanib + ranitidine then vandetanibvandetanib then vandetanib + omeprazolevandetanib then vandetanib + ranitidine
omeprazoleDRUG

Oral capsules, 40 mg, multiple doses

vandetanib + omeprazole then vandetanibvandetanib then vandetanib + omeprazole
ranitidineDRUG

Oral tables, 150 mg, multiple doses

vandetanib + ranitidine then vandetanibvandetanib then vandetanib + ranitidine

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Publications (1)

  • Johansson S, Read J, Oliver S, Steinberg M, Li Y, Lisbon E, Mathews D, Leese PT, Martin P. Pharmacokinetic evaluations of the co-administrations of vandetanib and metformin, digoxin, midazolam, omeprazole or ranitidine. Clin Pharmacokinet. 2014 Sep;53(9):837-47. doi: 10.1007/s40262-014-0161-2.

    PMID: 25117183DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Medullary

Interventions

vandetanibOmeprazoleRanitidine

Condition Hierarchy (Ancestors)

Carcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFurans

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 27, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

US(1)