A Phase 1 interventional study of baxdrostat (formerly CIN-107) oral solution in Hypertension, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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:
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 14 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.
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Exclusion Criteria:
5 mg CIN-107 oral solution in a fasted state
Drug: baxdrostat (formerly CIN-107) oral solution
5 mg CIN-107 tablet(s) in a fasted state
Drug: baxdrostat (formerly CIN-107) oral solution
5 mg CIN-107 tablet(s) in a fed state (standard high fat meal)
Drug: baxdrostat (formerly CIN-107) oral solution
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
Also known as: baxdrostat (formerly CIN-107) tablet
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.
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
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
Ran from Mar 2020 to primary completion in Apr 2020, 1 month.
Of 111 industry-sponsored phase 1 interventional studies under Hypertension, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 15. This study's 1 month is below that.
Counting every sponsor, half of 158 studies reached it within 9 months; a quarter within 2 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Baxdrostat