Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Midazolam (Drug); vandetanib (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): James Vasselli, SCIENCE DIR, Study Director, Affiliation: AstraZeneca Philip Leese, MD, Principal Investigator, Affiliation: Quintiles
Summary
The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of
Midazolam administered alone and in combination with Vandetanib.
Clinical Details
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)
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: AUC for midazolam administered alone and in combination with vandetanib 800 mgCmax for midazolam administered alone and in combination with vandetanib 800 mg
Secondary outcome: Frequency and severity of adverse eventsECG data Laboratory data Vital signs data Other PK parameters for midazolam administered alone and in combination with vandetanib 800 mg Vandetanib PK parameters for vandetanib in combination with midazolam
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)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
Research Site, Overland Park, Kansas, United States
Additional Information
CSR-D4200C00103.pdf Revised_CSP_redacted
Starting date: April 2012
Last updated: August 14, 2014
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