Pharmacokinetics
Conditions
Keywords
open label, 2-consecutive-group, 2-period, 1-sequence crossover study
Brief summary
The aim of this study is to examine the effect of coadministration of CYP3A4 inhibitors on the pharmacokinetics of AZD9742.
Interventions
DRUGAZD9742
Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL; On Day 7, a single 150 mg IV dose, coadministered after the morning dose of ketoconazole
DRUGDiltiazem
Orally, daily beginning on Day 4 for 14 consecutive days
DRUGketoconazole
200 mg, orally, every 12 hours starting on Day 4 for 10 consecutive days in which on Day 13 only the morning dose will be administered
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* non-childbearing potential, with suitable veins for cannulation or repeated venipuncture * Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening. * Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
Exclusion criteria
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate * History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator. * Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the effect of coadministration of CYP3A4 inhibitors (diltiazem and ketoconazole) on the pharmacokinetics of AZD9742 in blood and urine. | For diltiazem group - up to 18 days of pre-defined study days for pk profiling. For keoconazole - up to 14 days of pre-defined study days for pk profiling. |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, telemetry) | Collected prior to treatment, during treatment, and follow-up for a maximum of 57 days for group 1 and 53 days for group 2 (this includes up to 28 days for screening). |
Countries
United States
Outcome results
None listed