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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Digoxin; Drug: Vandetanib

• Registration Number: NCT01561781
• Lead Sponsor: Sanofi

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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
digoxin then digoxin + vandetanib	Digoxin	Digoxin alone followed by digoxin in combination with vandetanib
digoxin then digoxin + vandetanib	Vandetanib	Digoxin alone followed by digoxin in combination with vandetanib

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Frequency and severity of adverse events	Treatment period + 7-14 days

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States