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Completed

NCT Number: NCT05500820

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

This is a randomized, double-blind, study to assess the safety, tolerability, PK, and PD of multiple oral doses of CIN-107 when administered to healthy adult subjects.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
  • Nonsmokers who have not used nicotine-containing products for at least 6 months prior to the Screening Visit.

Exclusion criteria

  • 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.
  • A 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, or atrial fibrillation.
  • Prolonged QTcF (>450 msec) based on the average of triplicate ECGs.
  • Seated blood pressure higher than 150/90 mmHg or lower than 90/50 mmHg.
  • Resting heart rate higher than 100 bpm or lower than 50 bpm , sinus node dysfunction, or clinically significant heart block.
  • Temperature (T) greater than 37.6o C (99.68o F, measured orally), and respiration rate less than 12 and greater than 20 breaths/minute.
  • 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).
  • Serum potassium > upper limit of normal of the reference range (ULN) and serum sodium < lower limit of normal of the reference range (LLN).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values > 1.2 ULN.
  • Positive for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody, or Hepatitis B surface antigen (HBsAg).
  • A known history of porphyria, myopathy, or an active liver disease.
  • 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.
  • Typical consumption of ≥14 alcoholic drinks weekly.
  • Surgical procedures within 4 weeks of check-in or planned elective surgery during the study period.
  • Currently undergoing treatment with weight loss medication or prior weight loss surgery (eg, gastric bypass surgery).
  • Pregnant, breastfeeding, or planning to become pregnant during the study.

Treatment and study plan

CIN-107

Drug

A repeat oral dose of CIN-107 once daily for 10 days.

Other names: baxdrostat

Matching Placebo

Drug

A repeat oral dose of matching placebo once daily for 10 days.

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: up to Day 15

    This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first and last doses of CIN-107, as the data permit.

  2. Time to maximum plasma concentration (Tmax)

    Time frame: up to Day 15

    This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first and last doses of CIN-107, as the data permit.

  3. Area under the curve from time 0 to the time of last quantifiable plasma concentration (AUC[0-last])

    Time frame: up to Day 15

    This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.

  4. Area under the curve from time 0 to infinity

    Time frame: up to Day 15

    This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.

  5. Area under the curve over a dosing interval (tau)

    Time frame: up to Day 15

    This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.

  6. Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours

    Time frame: up to Day 2

    This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first dose of CIN-107, as the data permit.

  7. Percent of AUC extrapolated

    Time frame: up to Day 15

    This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.

  8. Terminal phase elimination half-life

    Time frame: up to Day 15

    This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.

  9. Apparent plasma clearance

    Time frame: up to Day 15

    This PK parameter will be determined for CIN-107 using plasma concentration data.

  10. Apparent volume of distribution

    Time frame: Up to Day 15

    This PK parameter will be determined for CIN-107 using plasma concentration data.

  11. The cumulative amount of CIN-107 and CIN-107-M excreted in the urine (Ae)

    Time frame: up to Day 15

    This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)

  12. Renal clearance (CLR Calculated as Ae/AUC) of CIN-107 and CIN-107-M

    Time frame: up to Day 15

    This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)

  13. Fraction of the dose excreted renally (fe)

    Time frame: up to Day 15

    This PK parameter will be calculated using the urine concentrations of CIN-107

  14. Number of patients experiencing adverse events (AEs)

    Time frame: up to Day 15

  15. Number of patients experiencing adverse drug reactions

    Time frame: up to Day 15

  16. Number of patients experiencing serious adverse events (SAEs)

    Time frame: up to Day 15

  17. Plasma concentration of aldosterone

    Time frame: up to Day 15

  18. Plasma renin activity

    Time frame: up to Day 15

  19. Plasma concentration of cortisol (free and total)

    Time frame: up to Day 15

  20. Plasma concentration of ACTH (Adrenocorticotropic hormone)

    Time frame: up to Day 15

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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