Healthy Volunteers
Conditions
Keywords
Phase 1, healthy volunteers, pharmacokinetics, vandetanib, midazolam
Brief summary
The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib.
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)
Interventions
DRUGMidazolam
Oral syrup 7.5 mg, single dose
DRUGvandetanib
Oral tablets, 800 mg, single dose
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC for midazolam administered alone and in combination with vandetanib 800 mg | Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose |
| Cmax for midazolam administered alone and in combination with vandetanib 800 mg | Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory data | Treatment period from 7 to 14 days |
| Vital signs data | Treatment period from 7 to 14 days |
| Frequency and severity of adverse events | Treatment period from 7 to 14 days |
| Vandetanib PK parameters for vandetanib in combination with midazolam | 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 |
| Other PK parameters for midazolam administered alone and in combination with vandetanib 800 mg | Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose |
| ECG data | Treatment period from 7 to 14 days |
Countries
United States
Outcome results
None listed