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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-07-31

Brief Summary

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

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Detailed Description

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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)

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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midazolam then midazolam + vandetanib

Midazolam alone followed by midazolam in combination with vandetanib

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Oral syrup 7.5 mg, single dose

vandetanib

Intervention Type DRUG

Oral tablets, 800 mg, single dose

Interventions

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Midazolam

Oral syrup 7.5 mg, single dose

Intervention Type DRUG

vandetanib

Oral tablets, 800 mg, single dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes