Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat
Study Details
Study Description
Brief Summary
This was a Phase 1, open-label, single dose study in healthy male subjects. The goals of this clinical trial were to determine how baxdrostat might be absorbed and metabolized using radioactive [14C] labeled baxdrostat. Subjects were administered a single oral dose of 10 mg containing approximately 100 μCi of [14C] baxdrostat. Subjects were to be confined to the study site for 9 to 15 days for blood, urine, and feces collections.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 10 mg [14C]-bexdrostat single oral dose of 10 mg baxdrostat containing 100 μCi of [14C] baxdrostat |
Drug: baxdrostat
a blood pressure lowering drug, oral dose
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Total radioactivity recovery in urine and feces following administration of [14C] baxdrostat. [1 to 15 days after dosing]
Measurement of total radioactivity recovery in urine and feces to determine the routes, rates of elimination, and mass balance of total radioactivity from [14C] baxdrostat.
- Area under the curve [AUC] of baxdrostat and its primary metabolite (CIN-107M) following administration of [14C] baxdrostat to healthy male subjects. [1 to 15 days after dosing]
Area under the curve (AUC)0-∞ and AUC0-last will be determined for baxdrostat and CIN-107M in plasma.
- Cumulative baxdrostat and CIN-107M excreted in urine and fraction of baxdrostat renally excreted following administration of [14C] baxdrostat to healthy subjects. [1 to 15 days after dosing]
Determining cumulative amount of baxdrostat and CIN-107M excreted in urine, clearance of baxdrostat and CIN-107M, and fraction of dose excreted renally (baxdrostat only).
- Maximum concentration [Cmax] for baxdrostat and CIN-107M in plasma. [1 to 15 days after dosing]
Cmax will be determined based on measurement of baxdrostat and CIN-107M in plasma.
- Time to maximum concentration [Tmax] for baxdrostat and CIN-107M in plasma. [1 to 15 days after dosing]
Tmax will be determined based on measurement of baxdrostat and CIN-107M in plasma.
- Terminal elimination half-life (t1/2) for baxdrostat and CIN-107M in plasma. [1 to 15 days after dosing]
t1/2 for baxdrostat and CIN-107M in plasma will be determined based on measurement of baxdrostat and CIN-107M in plasma.
Secondary Outcome Measures
- Quantitative metabolic profiles of baxdrostat in plasma and excreta. [1 to 15 days after dosing]
To determine, where possible, the quantitative metabolite profiles in plasma, urine, and feces after [14C]-baxdrostat
- Identification of baxdrostat metabolites in plasma and excreta. [1 to 15 days after dosing]
To determine, where possible, the chemical structure of major metabolites in plasma, urine, and feces after [14C]-baxdrostat
- Incidence of treatment emergent adverse events following administration of [14C] baxdrostat. [1 to 15 days after dosing]
Incidence of adverse events will be used to assess the safety and tolerability of [14C] baxdrostat when administered to healthy subjects.
Eligibility Criteria
Criteria
Subjects must meet the following inclusion criteria:
-
Be males of any race between 18 and 55 years of age
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Have a body mass index between 18.0 and 32.0 kg/m2
-
Be in good health, determined by no clinically significant findings from medical history
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Have normal renal function, defined as estimated GFR ≥70 mL/min/1.73 m2
-
Agree to use contraception
-
Be able to comprehend and willing to sign an ICF and to abide by the study restrictions
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Have a history of a minimum of 1 bowel movement per day
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Agree to refrain from donation of sperm from check-in until 90 days after discharge
Main Exclusion Criteria:
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Significant history or clinical manifestation of any diseases as determined by the investigator
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Prolonged QTcF (>450 msec)
-
Confirmed (eg, 2 consecutive measurements) systolic BP >140 or <90 mmHg, diastolic BP
90 or <50 mmHg, and pulse rate >100 or <45 beats per minute (bpm).
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Postural tachycardia (ie, >30 bpm upon standing) or orthostatic hypotension (ie, a fall in systolic BP of ≥20 mmHg or diastolic BP of ≥10 mmHg upon standing).
-
Serum potassium >upper limit of normal (5.3 mmol/L; ULN) of the reference range and serum sodium <lower limit of normal (135 mmol/L) of the reference range
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Aspartate aminotransferase, alanine aminotransferase, or total bilirubin values >1.2 × ULN.
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A known history of porphyria, myopathy, or active liver disease
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Use of any prescription medications
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Corticosteroid use (systemic or extensive topical use) within 3 months prior to dosing
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Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Labcorp Clinical Research Unit | Madison | Wisconsin | United States | 53704 |
Sponsors and Collaborators
- CinCor Pharma, Inc.
Investigators
- Principal Investigator: Nicholas Siebers, MD Siebers, MD, Labcorp Clinical Research Unit, Madison, Wisconsin, USA 53704
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIN-107-117