Research Site
Harrow, HA1 3UJ, United Kingdom
NCT Number: NCT05052710
The study is an open-label, fixed-sequence, cross-over study conducted at a single Clinical Unit to assess the pharmacokinetics (PK) of midazolam in healthy male and female (non-childbearing potential) subjects when administered alone and in combination with AZD4831 after multiple doses (once daily) of AZD4831 for 10 consecutive days.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Harrow, HA1 3UJ, United Kingdom
The study will consist of 2 treatment periods and will comprise:
Treatment Period 1: Midazolam only (Day 1). Treatment Period 2: AZD4831 only (Days 2 to 10, once daily dosing) and AZD4831 plus midazolam (Day 11).
Each subject will be involved in the study for approximately 7 weeks.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive oral doses once daily from Days 2-11.
Subjects will receive oral single doses on Day 1 and Day 11.
Time frame: Days 1, 2, 11, and 12
Effect of AZD4831 on AUCinf of Midazolam will be assessed.
Time frame: Days 1, 2, 11, and 12
Effect of AZD4831 on AUClast of Midazolam will be assessed.
Time frame: Days 1, 2, 11, and 12
Effect of AZD4831 on Cmax of Midazolam will be assessed.
Time frame: Midazolam:Days 1, 2, 11, and 12; AZD4831:Days 2-12
tmax of Midazolam and AZD4831 will be assessed.
Time frame: Midazolam:Days 1, 2, 11, and 12; AZD4831:Days 2-12
t½λz of Midazolam and AZD4831 will be assessed.
Time frame: Midazolam:Days 1, 2, 11, and 12; AZD4831:Days 2-12
CL/F of Midazolam and AZD4831 will be assessed.
Time frame: Days 1, 2, 11, and 12
Vz/F of Midazolam will be assessed.
Time frame: Days 2-12
AUCtau of AZD4831 will be assessed.
Time frame: Days 2-12
Cmax of AZD4831 will be assessed.
Time frame: Days 3-10
Pre-dose plasma concentration of AZD4831 will be assessed.
Time frame: Day 11
Plasma concentration of AZD4831 will be assessed.
Time frame: From Screening (Day -28 to Day -2) until Follow-up Visit (Day 20)
Safety and tolerability of AZD4831 alone and in combination with midazolam will be assessed.
AstraZeneca
Industry
A Fixed Sequence, Open-label Study to Assess the Effect of Multiple Doses of AZD4831 on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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