Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment

NCT ID: NCT05961397

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2022-04-15

Brief Summary

The goal of this Phase 1, open-label, single-dose, parallel-group study is to evaluate the pharmacokinetics (PK) of a single 10-mg oral dose of baxdrostat in subjects with varying degrees of hepatic function. The main objectives are to:

• To assess the safety and tolerability of baxdrostat following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function; and
• To characterize the PK of baxdrostat following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function.

Participants were administered a single 10-mg oral dose of baxdrostat in the fasted state the morning of Day 1. Plasma samples were drawn at various timepoints. Safety assessments included adverse events, vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory evaluations, and physical examinations.

Twenty subjects in 2 groups based on the Child-Pugh classification in the protocol at screening: up to 10 subjects in the normal hepatic function group and up to 10 subjects in the moderate hepatic impairment group. Twenty subjects entered and completed the study.

Conditions

Hypertension

Study Design

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

Study Groups

Normal hepatic function group

Subjects with normal hepatic function

Group Type: EXPERIMENTAL

baxdrostat

Intervention Type: DRUG

single oral dose of baxdrostat 10 mg

Moderate hepatic impairment group

Subjects with a Child-Pugh score of 7 to 9 (Category B) at screening

Group Type: EXPERIMENTAL

baxdrostat

Intervention Type: DRUG

single oral dose of baxdrostat 10 mg

Interventions

baxdrostat

single oral dose of baxdrostat 10 mg

Intervention Type: DRUG

Other Intervention Names

CIN-107

Eligibility Criteria

Inclusion Criteria

• Is between the ages of 18 and 80 years, inclusive, and in stable health condition. (For hepatically impaired subjects, their hepatic function category must be stable for a minimum of 3 months prior to screening.)
• Is a non-nicotine user or smokes =<10 cigarettes/day;
• Has a BMI between 18 and 42 kg/m2, inclusive;
• Is able to understand and willing to comply with study procedures and restrictions and provide written informed consent;
• if a male subject with a female partner of childbearing potential must agree to use 2 medically accepted, highly effective methods of birth control for 90 days.
• if male, must agree to abstain from sperm donation for 90 days; and
• if female with a male partner, must be surgically sterile, postmenopausal, or agree to use 2 medically accepted, highly effective methods of birth control from Day -14 until 60 days after study drug dosing

Exclusion Criteria

• 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;
• Prolonged QTcF (>460 msec) based on the average of triplicate ECGs;
• Estimated glomerular filtration rate (or creatinine clearance) <50 mL/min/1.73 m2;
• Evidence of any of the following: Encephalopathy grade 2 or worse, Seated systolic BP >160 mmHg and/or diastolic BP >100 mmHg, or systolic BP <90 mmHg and/or diastolic BP <50 mmHg, resting heart rate >100 beats per minute (bpm) or <50 bpm, Oral temperature >37.6°C (>99.68°F), Respiration rate <12 or >20 breaths per minute, symptomatic postural tachycardia or orthostatic hypotension, abnormal serum potassium >upper limit of normal range, abnormal serum sodium <130 mEq/L, positive test for HIV antibody, hepatitis C , hepatitis B , or SARS-CoV-2 RNA
• Current treatment with weight loss medication or prior weight loss surgery;
• Use of a moderate or strong inhibitor of CYP3A4 within 14 days prior to the dose of study drug OR use of a moderate or 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
• 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

Principal Investigators

Kimberly Cruz, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Pharma CR

William B Smith,, MD

Role: PRINCIPAL_INVESTIGATOR

Alliance for Multispecialty Research

Zeid Kayali, MD

Role: PRINCIPAL_INVESTIGATOR

Inland Empire Clinical Trials

Thomas Marbury, MD

Role: PRINCIPAL_INVESTIGATOR

Orlando Clinical Research Center

Eric Lawitz, MD

Role: PRINCIPAL_INVESTIGATOR

American Research Corporation at the Texas Liver Institute

Locations

Inland Empire Clinical Trials

Rialto, California, United States

Advanced Pharma CR

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Alliance for Multispecialty Research

Knoxville, Tennessee, United States

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, United States

Countries

United States

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CIN-107-115&attachmentIdentifier=39073201-1e04-4750-aff3-5f7739890c35&fileName=cin-107-115-csr-synopsis_Redacted.pdf&versionIdentifier=

Redacted CSR Synopsis

Other Identifiers

CIN-107-115

Identifier Type: -

Identifier Source: org_study_id