The goal of this study was to compare the characteristics of a new tablet formulation versus an oral solution of CIN-107 (baxdrostat) in terms of CIN-107 levels over time in the blood and to compare the effect of food on these parameters in healthy volunteer participants who received the CIN-107 tablet under fed versus fasted conditions.
The goals of this study were to: 1. To assess the safety and tolerability of single doses of CIN-107 tablet and oral solution in healthy participants. 2. Compare CIN-107 levels over time in the blood in participants after dosing between a tablet formulation of CIN-107 as compared to the oral solution. 3. Compare the CIN-107 levels over time in the blood in participants following dosing with a CIN-107 tablet after a meal versus in the fasted state. Participants took either the oral solution or a tablet of CIN-107 and had their safety and blood levels of CIN-107 measured over several days following administration of CIN-107 tablet either in the fasted state or after a meal. The CIN-107 blood levels over time were compared between the groups given either the oral solution or the tablet and between the group given the CIN-107 tablet with a meal versus in the fasted state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
5 mg single dose of baxdrostat given as either a solution or tablet in either the fed or fasted state, depending on the arm of the study
Medpace
Cincinnati, Ohio, United States
Incidence of treatment emergent adverse events following single oral doses of CIN-107 tablet and oral solution.
The safety and tolerability of CIN-107 will be assessed throughout the study based on quantitation of adverse events that occur following oral doses of CIN-107 tablet and oral solution.
Time frame: 0 to 23 days after dosing
Maximum concentration [Cmax] following administration of a tablet formulation of CIN-107 compared to Cmax following administration of the oral solution.
Cmax will be determined for CIN-107 and any other measured metabolites for participants given each formulation of baxdrostat; relative bioavailability will be evaluated by comparing these parameters between patients given the solution versus the tablet.
Time frame: 0 to 21 days after dosing
Cmax of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
Cmax will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions; food effect will be evaluated by comparing Cmax between participants under each condition.
Time frame: 0 to 21 days after dosing
Area under the curve [AUC] following administration of a tablet formulation of CIN-107 compared to AUC following administration of the oral solution.
Area under the curve (AUC)0-∞ and AUC0-last will be determined for baxdrostat and any other measured metabolites for participants given each formulation of baxdrostat. Then relative bioavailability will be evaluated by comparing these AUC parameters between patients given the solution versus the tablet.
Time frame: 0 to 21 days after dosing
Time to maximum concentration [Tmax] of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
Tmax will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions, and then food effect will be evaluated by comparing Tmax between participants under each condition.
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Time frame: 0 to 21 days after dosing
AUC of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
Area under the curve (AUC)0-∞ and AUC0-last will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions, and then food effect will be evaluated by comparing AUC between participants under each condition.
Time frame: 0 to 21 days after dosing
Tmax following administration of a tablet formulation of CIN-107 compared to Tmax following administration of the oral solution.
Tmax will be determined for CIN-107 and any other measured metabolites for participants given each formulation of baxdrostat.
Time frame: 0 to 21 days after dosing
Angiotensin converting enzyme (ACE) levels following single doses of CIN-107.
An exploratory assessment of the effect of CIN-107 on various measures associated with the Renin-Angiotensin-Aldosterone system including, but not limited to, angiotensin converting enzyme (ACE).
Time frame: 0 to 21 days after dosing