Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat

NCT ID: NCT05961384

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2022-01-15

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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

10 mg [14C]-bexdrostat

single oral dose of 10 mg baxdrostat containing 100 μCi of \[14C\] baxdrostat

Group Type: EXPERIMENTAL

baxdrostat

Intervention Type: DRUG

a blood pressure lowering drug, oral dose

Interventions

baxdrostat

a blood pressure lowering drug, oral dose

Intervention Type: DRUG

Other Intervention Names

CIN-107

Eligibility Criteria

Inclusion Criteria

• Be males of any race between 18 and 55 years of age
• 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
• 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
• Have a history of a minimum of 1 bowel movement per day
• Agree to refrain from donation of sperm from check-in until 90 days after discharge

Exclusion Criteria

• Significant history or clinical manifestation of any diseases as determined by the investigator
• 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).
• 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
• Aspartate aminotransferase, alanine aminotransferase, or total bilirubin values >1.2 × ULN.
• A known history of porphyria, myopathy, or active liver disease
• Use of any prescription medications
• Corticosteroid use (systemic or extensive topical use) within 3 months prior to dosing
• Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Siebers, MD Siebers, MD

Role: PRINCIPAL_INVESTIGATOR

Labcorp Clinical Research Unit, Madison, Wisconsin, USA 53704

Locations

Labcorp Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CIN-107-117&attachmentIdentifier=5f19d8f3-3b9c-4b19-bdec-20fa3b299f06&fileName=CIN-107-117_(1).xml&versionIdentifier=

CSR Synopsis Redacted

Other Identifiers

CIN-107-117

Identifier Type: -

Identifier Source: org_study_id