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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Treatments: Midazolam

Criteria

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.