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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01561781

Acronym

Vandetanib

Enrollment

Registered

2012-03-23

Start date

2012-03-31

Completion date

2012-07-31

Last updated

2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Phase 1, healthy volunteers, pharmacokinetics, vandetanib, digoxin

Brief summary

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

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

Interventions

DRUGDigoxin

Oral tablets 0.25mg, single dose

DRUGVandetanib

Oral tablets, 300 mg, single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Laboratory data	Treatment period + 7-14 days
Vital signs data	Treatment period + 7-14 days
Frequency and severity of adverse events	Treatment period + 7-14 days
Digoxin PK parameters for vandetanib in combination with digoxin	Predose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 48, 72, and 96 hrs post dose
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
ECG data	Treatment period + 7-14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026