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

Healthy Volunteers Clinical Trial

— Vandetanib  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561781
• Other study ID #: D4200C00100
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2012
• Last updated: August 26, 2016
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: August 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Digoxin
Oral tablets 0.25mg, single dose
• Vandetanib
Oral tablets, 300 mg, single dose

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Frequency and severity of adverse events		Treatment period + 7-14 days	Yes
Secondary	ECG data		Treatment period + 7-14 days	Yes
Secondary	Laboratory data		Treatment period + 7-14 days	Yes
Secondary	Vital signs data		Treatment period + 7-14 days	Yes
Secondary	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	No
Secondary	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	No

External Links

•   Link
•   CSR-D4200C00100.pdf
•   Revised_CSP_redacted