Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Midazolam; Drug: vandetanib

• Registration Number: NCT01544140
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed 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)

Study Timeline

• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-03-05
• Study Start: 2012-04
• 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: 16

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
midazolam then midazolam + vandetanib	Midazolam	Midazolam alone followed by midazolam in combination with vandetanib
midazolam then midazolam + vandetanib	vandetanib	Midazolam alone followed by midazolam in combination with vandetanib

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events	Treatment period from 7 to 14 days
ECG data	Treatment period from 7 to 14 days
Laboratory data	Treatment period from 7 to 14 days
Vital signs data	Treatment period from 7 to 14 days
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
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

Trial Locations

Locations (1)

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