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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01561781
First received: March 21, 2012
Last updated: July 26, 2012
Last verified: July 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 AstraZeneca:

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 ] [ Designated as safety issue: No ]
  • 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 ] [ 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 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 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 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
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: NCT01561781

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01561781     History of Changes
Other Study ID Numbers: D4200C00100
Study First Received: March 21, 2012
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 23, 2014