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)
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)
Inclusion Criteria:
Provision of signed and dated, written informed consent prior to any study
specific procedures:
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:
Positive screen for drugs of abuse.