Study to Evaluate the Pharmacokinetics of CIN-107 in Subjects With Varying Degrees of Renal Function

NCT ID: NCT05470725

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2021-04-30

Brief Summary

This is a Phase 1, open-label, parallel-group study in subjects with varying degrees of renal function to assess the safety, tolerability, and Pharmacokinetics of a single 10 mg oral dose of CIN-107.

Conditions

Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control (normal renal function or mild renal impairment)

Estimated glomerular filtration rate (eGFR) ≥60 mL/min

Group Type: EXPERIMENTAL

CIN-107

Intervention Type: DRUG

A single 10 mg CIN-107 oral dose (2 X 5 mg tablets).

Moderate to severe renal impairment

eGFR 15 to 59 mL/min

Group Type: EXPERIMENTAL

CIN-107

Intervention Type: DRUG

A single 10 mg CIN-107 oral dose (2 X 5 mg tablets).

Kidney failure

eGFR <15 mL/min, including:

• Subjects not on dialysis; and
• Subjects on dialysis, with study drug administration on a non-dialysis day

Group Type: EXPERIMENTAL

CIN-107

Intervention Type: DRUG

A single 10 mg CIN-107 oral dose (2 X 5 mg tablets).

Interventions

CIN-107

A single 10 mg CIN-107 oral dose (2 X 5 mg tablets).

Intervention Type: DRUG

Other Intervention Names

baxdrostat

Eligibility Criteria

Inclusion Criteria

• Subjects in stable health based on medical and psychiatric history, physical examination, ECG, vital signs (seated and orthostatic), and routine laboratory tests (chemistry, hematology, coagulation, and urinalysis); Note: Underlying medical conditions consistent with the population under study are acceptable if the subject's condition is considered stable by the Investigator. For renally impaired subjects, their renal status must be stable for a minimum of 3 months prior to screening.
• Does not use nicotine-containing products at all or smokes <10 cigarettes/day (approximately <half pack/day);
• Body mass index (BMI) between 18 and 40 kg/m2, inclusive;

Exclusion Criteria

• Active participation in another experimental therapy study of a small molecule other than CIN-107 within 30 days prior to Day 1 or 5 half-lives, whichever is longer; or received a large molecule within 90 days prior to Day 1 or 5 half-lives, whichever is longer;
• History of prior organ transplant or planned transplant within 6 months of screening;
• Personal or family history of long QT syndrome, torsades de pointes, or other complex ventricular arrhythmias, or family history of sudden death;
• History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, chronic persistent atrial fibrillation, sinus node dysfunction, or clinically significant heart block. Subjects with minor forms of ectopy (eg, premature atrial contractions) are not necessarily excluded;
• Prolonged QTcF (>450 msec for males or >470 msec for females) based on the average of triplicate ECGs;
• Evidence of any of the following clinical measurements:

1. Seated systolic BP >160 mmHg and/or diastolic BP >100 mmHg, or systolic BP <90 mmHg and/or diastolic BP <50 mmHg;

2. Resting heart rate >100 beats per minute (bpm) or <50 bpm;

3. Oral temperature >37.6°C (>99.68°F);

4. Respiration rate 20 breaths/minute;

5. Postural tachycardia (ie, an increase in heart rate >30 bpm upon standing from a seated position);

6. Orthostatic hypotension (ie, a fall in systolic BP ≥20 mmHg or diastolic BP ≥10 mmHg upon standing from a seated position);

7. Clinically significant abnormal serum potassium >upper limit of normal of the reference range (ULN);

8. Clinically significant abnormal serum sodium 1.5 x ULN;

9. Aspartate aminotransferase or alanine aminotransferase values >1.5 x ULN

10. Total bilirubin >2 x ULN, unless due to Gilbert's syndrome;

11. Positive test for HIV antibody, hepatitis C virus (HCV) RNA, hepatitis B surface antigen (HBsAg), or SARS-CoV-2 RNA; or

• History of porphyria, myopathy, or active liver disease;
• Inadequate venous access;
• Current treatment with weight loss medication or prior weight loss surgery (eg, gastric bypass surgery);
• Use of a strong inducer of CYP3A4 within 28 days prior to the dose of study drug;
• Corticosteroid use (systemic or extensive topical use) within 3 months prior to study drug dosing;
• Positive drug or alcohol test result without medical explanation or a history of alcoholism or drug abuse within 2 years prior to study drug dosing as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition;
• Typical consumption of ≥14 alcoholic drinks weekly;
• Surgical procedures within 4 weeks prior to study drug dosing or planned elective surgery during the study period;
• Any clinically significant illness within 4 weeks prior to study drug dosing, unless deemed not clinically significant by the Investigator;
• Pregnant, breastfeeding, or planning to become pregnant during the study;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orlando Clinical Research Center

Orlando, Florida, United States

Genesis Clinical Trials

Tampa, Florida, United States

Countries

United States

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CIN-107-113&attachmentIdentifier=470157a5-c75d-4658-984f-d465ba903b3e&fileName=cin-107-113-report-synopsis_Redacted.pdf&versionIdentifier=

Redacted CSR Synopsis

Other Identifiers

CIN-107-113

Identifier Type: -

Identifier Source: org_study_id