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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01544140
First received: February 23, 2012
Last updated: July 26, 2012
Last verified: July 2012
History of Changes

February 23, 2012
July 26, 2012
April 2012
July 2012   (final data collection date for primary outcome measure)
  • AUC for midazolam administered alone and in combination with vandetanib 800 mg [ Time Frame: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose ] [ Designated as safety issue: No ]
  • Cmax for midazolam administered alone and in combination with vandetanib 800 mg [ Time Frame: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01544140 on ClinicalTrials.gov Archive Site
  • Frequency and severity of adverse events [ Time Frame: Treatment period from 7 to 14 days ] [ Designated as safety issue: Yes ]
  • ECG data [ Time Frame: Treatment period from 7 to 14 days ] [ Designated as safety issue: Yes ]
  • Laboratory data [ Time Frame: Treatment period from 7 to 14 days ] [ Designated as safety issue: Yes ]
  • Vital signs data [ Time Frame: Treatment period from 7 to 14 days ] [ Designated as safety issue: Yes ]
  • Other PK parameters for midazolam administered alone and in combination with vandetanib 800 mg [ Time Frame: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose ] [ Designated as safety issue: No ]
  • Vandetanib PK parameters for vandetanib in combination with midazolam [ Time Frame: 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib
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)

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

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)
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Midazolam
    Oral syrup 7.5 mg, single dose
  • Drug: vandetanib
    Oral tablets, 800 mg, single dose
Experimental: midazolam then midazolam + vandetanib
Midazolam alone followed by midazolam in combination with vandetanib
Interventions:
  • Drug: Midazolam
  • Drug: vandetanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01544140
D4200C00103
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: James Vasselli, SCIENCE DIR AstraZeneca
Principal Investigator: Philip Leese, MD Quintiles
AstraZeneca
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP