Study with CIN-107 Following Multiple Oral Ascending Doses in Healthy Subjects

Study identifier:CIN-107-111

ClinicalTrials.gov identifier:NCT05500820

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CIN-107 Following Multiple Oral Doses in Healthy Subjects

Medical condition

hypertension

Phase

Phase 1

Healthy volunteers

Yes

Study drug

CIN-107, Matching Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 19 Dec 2019

Primary Completion Date: 03 Apr 2020

Study Completion Date: 03 Apr 2020

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Healthy subjects between the ages of 18 and 55 years, inclusive, in good health based on medical and psychiatric history, physical examination, ECG, orthostatic vital signs, and routine laboratory tests (blood chemistry, hematology, coagulation, and urinalysis).
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
3. Nonsmokers who have not used nicotine-containing products for at least 6 months prior to the Screening Visit.

Exclusion Criteria

1. Actively participating in an experimental therapy study; received experimental therapy with a small molecule within 30 days of Day 1, or 5 half-lives, whichever is longer; or received experimental therapy with a large molecule within 90 days of Day 1, or 5 half-lives, whichever is longer.
2. A personal or family history of long QT syndrome, Torsades de Pointes, or other complex ventricular arrhythmias, or family history of sudden death.
3. History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, or atrial fibrillation.
4. Prolonged QTcF (>450 msec) based on the average of triplicate ECGs.
5. Seated blood pressure higher than 150/90 mmHg or lower than 90/50 mmHg.
6. Resting heart rate higher than 100 bpm or lower than 50 bpm , sinus node dysfunction, or clinically significant heart block.
7. Temperature (T) greater than 37.6o C (99.68o F, measured orally), and respiration rate less than 12 and greater than 20 breaths/minute.
8. Postural tachycardia (ie >30 bpm upon standing) or orthostatic hypotension (ie, a fall in systolic blood pressure (SBP) of ≥20 mm Hg or DBP of ≥ 10 mm Hg when a person assumes a standing position).
9. Serum potassium > upper limit of normal of the reference range (ULN) and serum sodium < lower limit of normal of the reference range (LLN).
10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values > 1.2 ULN.
11. Positive for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody, or Hepatitis B surface antigen (HBsAg).
12. A known history of porphyria, myopathy, or an active liver disease.
13. Positive drug or alcohol test result or a history of alcoholism or drug abuse within 2 years prior to the first dose of study drug as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition: DSM-IV.
14. Typical consumption of ≥14 alcoholic drinks weekly.
15. Surgical procedures within 4 weeks of check-in or planned elective surgery during the study period.
16. Currently undergoing treatment with weight loss medication or prior weight loss surgery (eg, gastric bypass surgery).
17. Pregnant, breastfeeding, or planning to become pregnant during the study.

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1: 2.5 mg CIN-107 Subjects on a low salt diet	Drug: CIN-107 A repeat oral dose of CIN-107 once daily for 10 days. Other Name: baxdrostat
Experimental: Cohort 2: 5.0 mg CIN-107 Subjects on a low salt diet	Drug: CIN-107 A repeat oral dose of CIN-107 once daily for 10 days. Other Name: baxdrostat
Experimental: Cohort 3: 1.5 mg CIN-107 Subjects on a normal salt diet	Drug: CIN-107 A repeat oral dose of CIN-107 once daily for 10 days. Other Name: baxdrostat
Experimental: Cohort 4: 2.5 mg CIN-107 Subjects on a normal salt diet	Drug: CIN-107 A repeat oral dose of CIN-107 once daily for 10 days. Other Name: baxdrostat
Experimental: Cohort 5: 0.5 mg CIN-107 Subjects on a normal salt diet	Drug: CIN-107 A repeat oral dose of CIN-107 once daily for 10 days. Other Name: baxdrostat
Placebo Comparator: Cohort 1: 2.5 mg matching placebo Subjects on a low salt diet	Drug: Matching Placebo A repeat oral dose of matching placebo once daily for 10 days.
Placebo Comparator: Cohort 2: 5.0 mg matching placebo Subjects on a low salt diet	Drug: Matching Placebo A repeat oral dose of matching placebo once daily for 10 days.
Placebo Comparator: Cohort 3: 1.5 mg matching placebo Subjects on a normal salt diet	Drug: Matching Placebo A repeat oral dose of matching placebo once daily for 10 days.
Placebo Comparator: Cohort 4: 2.5 mg matching placebo Subjects on a normal salt diet	Drug: Matching Placebo A repeat oral dose of matching placebo once daily for 10 days.
Placebo Comparator: Cohort 5: 0.5 mg matching placebo Subjects on a normal salt diet	Drug: Matching Placebo A repeat oral dose of matching placebo once daily for 10 days.

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

Leela Vrishabhendra

Medpace Clinical Pharmacology Unit