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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: vandetanib; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01544140

D4200C00103

Details and patient eligibility

About

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

Full 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)

Enrollment: 16 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

midazolam then midazolam + vandetanib

Experimental group

Description:

Midazolam alone followed by midazolam in combination with vandetanib

Treatment:

Drug: Midazolam

Drug: vandetanib