High Risk Coronary Artery Disease Clinical Trial
Official title:
A Randomized, 5-Period, 5-Treatment, Single-Dose, Open-Label, Single-Center, Crossover Study to Estimate the Effect of AZD5718 on the Pharmacokinetics of Rosuvastatin, and to Assess the Relative Bioavailability of AZD5718 Oral Suspension vs AZD5718 IR Tablet Formulation and the Food Effect of AZD5718.
This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center, crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs AZD5718 immediate release (IR) Tablet Formulation and the Food Effect of AZD5718 in Healthy Volunteers. The study will be performed at a single study center.
The study will comprise:
- A Screening period of maximum 28 days;
- Five treatment periods during which subjects will be resident from the morning on the
day before dosing with the IMP (Day -1) until at least 48 hours after dosing; discharge
will be on the morning of Day 3, and
- A Follow-up Visit within 7 to 10 days after the last administration of the IMPs.
- There will be a minimum of a 7 days washout between each treatment period.
Each subject will receive 5 treatments. The following treatments will be given:
- Treatment A: 10 mg rosuvastatin tablet alone (fasting state)
- Treatment B: 10 mg rosuvastatin tablet + 200 mg of AZD5718 IR tablet (2 x 100 mg
tablet) (fasting state)
- Treatment C: 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)
- Treatment D: 200 mg of AZD5718 oral suspension 50 mg/mL (fasting state)
- Treatment E: 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fed state)
Each subject will be involved in the study for approximately 8 weeks.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04087915 -
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With High Risk Coronary Artery Disease (FORWARD)
|