Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam 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 Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination With a Single Dose of 800-mg Vandetanib (CAPRELSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544140
• Other study ID #: D4200C00103
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2012
• Last updated: August 26, 2016
• Start date: April 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

The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib.

Description:

A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination with a Single Dose of 800-mg Vandetanib (CAPRELSA)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 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 50 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 smoke more than 5 cigarettes per day or are unable to refrain from smoking while resident in the study center

• 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:
• Midazolam
Oral syrup 7.5 mg, single dose
• vandetanib
Oral tablets, 800 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 midazolam administered alone and in combination with vandetanib 800 mg		Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose	No
Primary	Cmax for midazolam administered alone and in combination with vandetanib 800 mg		Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose	No
Secondary	Frequency and severity of adverse events		Treatment period from 7 to 14 days	Yes
Secondary	ECG data		Treatment period from 7 to 14 days	Yes
Secondary	Laboratory data		Treatment period from 7 to 14 days	Yes
Secondary	Vital signs data		Treatment period from 7 to 14 days	Yes
Secondary	Other PK parameters for midazolam administered alone and in combination with vandetanib 800 mg		Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose	No
Secondary	Vandetanib PK parameters for vandetanib in combination with midazolam		Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216 hrs post dose	No

External Links

•   Link
•   CSR-D4200C00103.pdf
•   Revised_CSP_redacted