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This is a randomized, double-blind, study to assess the safety, tolerability, PK, and PD of multiple oral doses of CIN-107 when administered to healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 2.5 mg CIN-107 | Experimental | Subjects on a low salt diet |
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| Cohort 2: 5.0 mg CIN-107 | Experimental | Subjects on a low salt diet |
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| Cohort 3: 1.5 mg CIN-107 | Experimental | Subjects on a normal salt diet |
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| Cohort 4: 2.5 mg CIN-107 | Experimental | Subjects on a normal salt diet |
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| Cohort 5: 0.5 mg CIN-107 | Experimental | Subjects on a normal salt diet |
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| Cohort 1: 2.5 mg matching placebo | Placebo Comparator | Subjects on a low salt diet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIN-107 | Drug | A repeat oral dose of CIN-107 once daily for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first and last doses of CIN-107, as the data permit. | up to Day 15 |
| Time to maximum plasma concentration (Tmax) | This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first and last doses of CIN-107, as the data permit. | up to Day 15 |
| Area under the curve from time 0 to the time of last quantifiable plasma concentration (AUC[0-last]) | This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit. | up to Day 15 |
| Area under the curve from time 0 to infinity | This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit. | up to Day 15 |
| Area under the curve over a dosing interval (tau) | This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit. | up to Day 15 |
| Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leela Vrishabhendra, MD | Medpace Clinical Pharmacology Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace Clinical Pharmacology Unit | Cincinnati | Ohio | 45227 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36266539 | Background | Freeman MW, Bond M, Murphy B, Hui J, Isaacsohn J. Results from a phase 1, randomized, double-blind, multiple ascending dose study characterizing the pharmacokinetics and demonstrating the safety and selectivity of the aldosterone synthase inhibitor baxdrostat in healthy volunteers. Hypertens Res. 2023 Jan;46(1):108-118. doi: 10.1038/s41440-022-01070-4. Epub 2022 Oct 20. |
| Label | URL |
|---|---|
| Redacted CSR Synopsis | View source |
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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.
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.
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.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Cohort 2: 5.0 mg matching placebo | Placebo Comparator | Subjects on a low salt diet |
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| Cohort 3: 1.5 mg matching placebo | Placebo Comparator | Subjects on a normal salt diet |
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| Cohort 4: 2.5 mg matching placebo | Placebo Comparator | Subjects on a normal salt diet |
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| Cohort 5: 0.5 mg matching placebo | Placebo Comparator | Subjects on a normal salt diet |
|
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| Matching Placebo | Drug | A repeat oral dose of matching placebo once daily for 10 days. |
|
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first dose of CIN-107, as the data permit.
| up to Day 2 |
| Percent of AUC extrapolated | This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit. | up to Day 15 |
| Terminal phase elimination half-life | This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit. | up to Day 15 |
| Apparent plasma clearance | This PK parameter will be determined for CIN-107 using plasma concentration data. | up to Day 15 |
| Apparent volume of distribution | This PK parameter will be determined for CIN-107 using plasma concentration data. | Up to Day 15 |
| The cumulative amount of CIN-107 and CIN-107-M excreted in the urine (Ae) | This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M) | up to Day 15 |
| Renal clearance (CLR Calculated as Ae/AUC) of CIN-107 and CIN-107-M | This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M) | up to Day 15 |
| Fraction of the dose excreted renally (fe) | This PK parameter will be calculated using the urine concentrations of CIN-107 | up to Day 15 |
| Number of patients experiencing adverse events (AEs) | up to Day 15 |
| Number of patients experiencing adverse drug reactions | up to Day 15 |
| Number of patients experiencing serious adverse events (SAEs) | up to Day 15 |
| Plasma concentration of aldosterone | up to Day 15 |
| Plasma renin activity | up to Day 15 |
| Plasma concentration of cortisol (free and total) | up to Day 15 |
| Plasma concentration of ACTH (Adrenocorticotropic hormone) | up to Day 15 |