NCT01561781

Brief Summary

This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin administered alone and in combination with Vandetanib.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2012

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

March 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

March 21, 2012

Last Update Submit

August 26, 2016

Conditions

Healthy Volunteers

Keywords

Phase 1healthy volunteerspharmacokineticsvandetanibdigoxin

Outcome Measures

Primary Outcomes (2)

  • AUC for digoxin administered alone and in combination with vandetanib 300 mg

    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

    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 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 digoxin administered alone and in combination with vandetanib 300 mg

    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

  • +1 more secondary outcomes

Study Arms (1)

digoxin then digoxin + vandetanib

EXPERIMENTAL

Digoxin alone followed by digoxin in combination with vandetanib

Drug: DigoxinDrug: Vandetanib

Interventions

DigoxinDRUG

Oral tablets 0.25mg, single dose

digoxin then digoxin + vandetanib
VandetanibDRUG

Oral tablets, 300 mg, single dose

digoxin then digoxin + vandetanib

Eligibility Criteria

Age18 Years - 45 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 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.

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 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.

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

Interventions

Digoxinvandetanib

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

US(1)