Primary objective: 1. To assess the potential inhibitory and inducing effect of oral givinostat on the single dose pharmacokinetics (PK) of intravenous or oral midazolam. 2. To assess the potential inhibitory and inducing effect of oral givinostat on the single dose PK of oral dabigatran etexilate. Secondary objective: To assess the safety and tolerability of concomitant administration of givinostat plus midazolam and dabigatran etexilate.
Age range
18 Years – 55 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Cmax for Midazolam, 1-hydroxymidazolam, Following Single Doses of the Parent Drug
Timeframe: In the turn of 24 hours after IV midazolam, single dose, administered at day 1,6,17 or after oral midazolam, single dose, administered at days 2, 7 and 18.
Cmax for Dabigatran (Total and Free), Following Single Doses of the Parent Drug
Timeframe: In the turn of 72 hours after administration of dabigatran on day 1,6,17
Tmax for Midazolam, 1-hydroxymidazolam, Following Single Doses of the Parent Drug
Timeframe: In the turn of 24 hours after IV midazolam, single dose, administered at day 1,6,17 or after oral midazolam, single dose, administered at days 2, 7 and 18.
Tmax for Dabigatran (Total and Free), Following Single Doses of the Parent Drug
Timeframe: In the turn of 72 hours after administration of dabigatran on day 1,6,17
t1/2 of Midazolam, 1-hydroxymidazolam, Following Single Doses of Givinostat
Timeframe: In the turn of 24 hours after IV midazolam, single dose, administered at day 1,6,17 or after oral midazolam, single dose, administered at days 2, 7 and 18.
t1/2 for Dabigatran (Total and Free), Following Single Doses of the Parent Drug
Timeframe: In the turn of 72 hours after administration of dabigatran on day 1,6,17
AUC0-t of Midazolam, 1-hydroxymidazolam, Following Single Doses of Givinostat
Timeframe: In the turn of 24 hours after IV midazolam, single dose, administered at day 1,6,17 or after oral midazolam, single dose, administered at days 2, 7 and 18.
AUC0-t for Dabigatran (Total and Free), Following Single Doses of the Parent Drug
Timeframe: In the turn of 72 hours after administration of dabigatran on day 1,6,17
AUC0-inf of Midazolam, 1-hydroxymidazolam, Following Single Doses of Givinostat
Timeframe: In the turn of 24 hours after IV midazolam, single dose, administered at day 1,6,17 or after oral midazolam, single dose, administered at days 2, 7 and 18.
AUC0-inf for Dabigatran (Total and Free), Following Single Doses of the Parent Drug
Timeframe: In the turn of 72 hours after administration of dabigatran on day 1,6,17
%AUCextrap of Midazolam, 1-hydroxymidazolam, Following Single Doses of Givinostat
Timeframe: In the turn of 24 hours after IV midazolam, single dose, administered at day 1,6,17 or after oral midazolam, single dose, administered at days 2, 7 and 18.
%AUC0extrap (%) for Dabigatran (Total and Free), Following Single Doses of the Parent Drug
Timeframe: In the turn of 72 hours after administration of dabigatran on day 1,6,17
λz of Midazolam, 1-hydroxymidazolam, Following Single Doses of Givinostat
Timeframe: In the turn of 24 hours after IV midazolam, single dose, administered at day 1,6,17 or after oral midazolam, single dose, administered at days 2, 7 and 18.
λz of Dabigatran (Total and Free), Following Single Doses of Givinostat
Timeframe: In the turn of 24 hours after IV midazolam, single dose, administered at day 1,6,17 or after oral midazolam, single dose, administered at days 2, 7 and 18.