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Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of Digoxin Administered Alone and in Combination With Vandetanib (Vandetanib)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01561781
First Posted: March 23, 2012
Last Update Posted: August 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose
This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin administered alone and in combination with Vandetanib.

Condition Intervention Phase
Healthy Volunteers Drug: Digoxin Drug: Vandetanib Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With a Single Dose of Vandetanib (CAPRELSA) 300 mg

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • AUC for digoxin administered alone and in combination with vandetanib 300 mg [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose ]
  • Cmax for digoxin administered alone and in combination with vandetanib 300 mg [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose ]

Secondary Outcome Measures:
  • Frequency and severity of adverse events [ Time Frame: Treatment period + 7-14 days ]
  • ECG data [ Time Frame: Treatment period + 7-14 days ]
  • Laboratory data [ Time Frame: Treatment period + 7-14 days ]
  • Vital signs data [ Time Frame: Treatment period + 7-14 days ]
  • Other PK parameters for digoxin administered alone and in combination with vandetanib 300 mg [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose ]
  • Digoxin PK parameters for vandetanib in combination with digoxin [ Time Frame: Predose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 48, 72, and 96 hrs post dose ]

Enrollment: 14
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: digoxin then digoxin + vandetanib
Digoxin alone followed by digoxin in combination with vandetanib
Drug: Digoxin
Oral tablets 0.25mg, single dose
Drug: Vandetanib
Oral tablets, 300 mg, single dose

Detailed Description:
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination with a Single Dose of Vandetanib (CAPRELSA) 300 mg
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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 45 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 are current smokers and have smoked or used nicotine products within the previous 6 months
  • 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, and human immunodeficiency virus (HIV), or positive screen for drugs of abuse.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561781


Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01561781     History of Changes
Other Study ID Numbers: D4200C00100
First Submitted: March 21, 2012
First Posted: March 23, 2012
Last Update Posted: August 29, 2016
Last Verified: August 2016

Keywords provided by Sanofi:
Phase 1
healthy volunteers
pharmacokinetics
vandetanib
digoxin

Additional relevant MeSH terms:
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs