Study identifier:D7550C00011
ClinicalTrials.gov identifier:NCT04492709
EudraCT identifier:N/A
CTIS identifier:N/A
A Fixed Sequence, Open-Label Study to Assess the Effect of Multiple Doses of AZD5718 on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Healthy Subjects
cardiovascular disease
Phase 1
Yes
AZD5718, Midazolam
All
14
Interventional
18 Years - 55 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Other
Verified 01 Oct 2022 by AstraZeneca
AstraZeneca
Parexel International
In clinical practice, AZD5718 will be co-administered with CYP3A substrates. Therefore, it is important to determine the impact of AZD5718 on the pharmacokinetics (PK) of CYP3A4 substrates. The primary objective of this study is to evaluate the effect of AZD5718 on the PK of midazolam, a known sensitive CYP3A4 substrate.
This is a Phase 1, fixed sequence, open-label study in healthy subjects, performed at a single study center. This study will consist of 3 treatment periods to assess the PK of midazolam when administered alone and in combination with multiple doses of AZD5718. The study will comprise: • A screening period of maximum 28 days; • Three treatment periods during which subjects will be resident from the day before first dosing (Day -1) until at least 24 hours after last dosing (Day 7); discharged on the morning of Day 8, and; • A final Follow-up Visit within 5 to 7 days after the last administration of investigational medicinal product (IMP).
Location
Location
Harrow, United Kingdom, HA1 3UJ
Arms | Assigned Interventions |
---|---|
Experimental: Treatment The subjects will receive oral midazolam solution of 2 mg as a single dose on 2 occasions, 6 days apart (Days 1 and 7). The first dose will be prior to dosing with oral AZD5718 tablet and the second dose after five administrations of AZD5718 under fasted conditions. | Drug: Midazolam The subjects will receive single doses of midazolam solution 2 mg/mL orally on Day 1 alone in Treatment Period 1 and on Day 7 co-administered with oral AZD5718 tablet in Treatment Period 3. |
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