Phase 1 PK study to evaluate the PK of CIN-107 in subjects with hepatic impairment

Study identifier:CIN-107-115

ClinicalTrials.gov identifier:NCT05961397

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Pharmacokinetics of CIN-107 in Subjects With Varying Degrees of Hepatic Function

Medical condition

hypertension

Phase

Phase 1

Healthy volunteers

Yes

Study drug

baxdrostat

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 10 Aug 2021

Primary Completion Date: 15 Apr 2022

Study Completion Date: 15 Apr 2022

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2023 by AstraZeneca

Collaborators

Inclusion and exclusion 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
Main

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

No locations available

Arms	Assigned Interventions
Experimental: Normal hepatic function group Subjects with normal hepatic function	Drug: baxdrostat single oral dose of baxdrostat 10 mg Other Name: CIN-107
Experimental: Moderate hepatic impairment group Subjects with a Child-Pugh score of 7 to 9 (Category B) at screening	Drug: baxdrostat single oral dose of baxdrostat 10 mg Other Name: CIN-107

Documents available

Redacted CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Kimberly Cruz

Advanced Pharma CR