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

Sanofi

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Digoxin

Drug: Vandetanib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01561781

D4200C00100

Details and patient eligibility

About

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

Full 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

Enrollment

14 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.