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Completed

NCT Number: NCT05526690

Study to Evaluate the Effect of CIN-107 on the Pharmacokinetics of the MATE Substrate, Metformin, in Healthy Subjects

This is a randomized, open-label, two-period, crossover Phase 1 to assess the impact of CIN-107 on the pharmacokinetics (PK) of metformin and the safety and tolerability of coadministration of CIN-107 and metformin as compared to metformin alone.

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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, at Screening;
  • Body mass index between 18 and 30 kg/m2, inclusive;
  • In good health based on medical/surgical and psychiatric history, physical examination, electrocardiogram (ECG), vital signs (seated and orthostatic), and routine laboratory tests (serum chemistry, hematology, and urinalysis);
  • Normal renal function, defined as estimated glomerular filtration rate ≥85 mL/min/1.73 m2 at Screening and Day -1;
  • Nonsmokers who have not used nicotine-containing products (ie, cigarettes, nicotine patch, nicotine chewing gum, or electronic cigarettes) for at least 6 months prior to Screening;

Exclusion criteria

  • Actively participating in an experimental therapy study; received experimental therapy with a small molecule other than CIN-107 within 30 days of the first dose of study drug or 5 half-lives, whichever is longer; or received experimental therapy with a large molecule within 90 days of the first dose of study drug or 5 half-lives, whichever is longer;
  • A personal or family history of long QT syndrome, Torsades de Pointes, 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, atrial fibrillation, sinus node dysfunction, or clinically significant heart block. Subjects with minor forms of ectopy (eg, premature atrial contractions) are not necessarily excluded and may be discussed with the Medical Monitor for inclusion;
  • Prolonged QT interval corrected by Fridericia's formula (>450 msec);
  • Seated systolic blood pressure (BP) >140 mmHg and/or diastolic BP >90 mmHg or systolic BP <90 mmHg and/or diastolic BP <50 mmHg;
  • Postural tachycardia (ie, >30 bpm upon standing) or orthostatic hypotension (ie, a fall in systolic BP ≥20 mmHg or diastolic BP ≥10 mmHg upon standing);
  • Serum potassium >upper limit of normal (ULN) of the reference range and serum sodium <lower limit of normal of the reference range;
  • Aspartate aminotransferase, alanine aminotransferase, or total bilirubin values >1.2 × ULN;
  • Positive for human immunodeficiency virus antibody, hepatitis C virus antibody, hepatitis B surface antigen, or severe acute respiratory syndrome coronavirus 2 RNA;
  • Evidence or history of any clinically significant immunologic, hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, musculoskeletal, hepatic, psychiatric, neurologic, or allergic (including clinically significant or multiple drug allergies) disease; surgical conditions; cancer (with the exception of basal or squamous cell carcinoma of the skin and cancer that has resolved or has been in remission for >5 years prior to Screening); or any condition that, in the Investigator's opinion, may confound study procedures or results, impact subject safety, or interfere with the absorption, distribution, metabolism, or excretion of the study drug (appendectomy allowed, cholecystectomy prohibited);
  • Typical consumption of ≥14 alcoholic drinks weekly; Note: 1 drink of alcohol is equivalent to ½ pint of beer (285 mL), 1 glass of spirits (25 mL), or 1 glass of wine (125 mL).
  • Surgical procedures within 4 weeks prior to Check-In (other than minor cosmetic surgery or minor dental procedures) or planned elective surgery during the treatment period;

Treatment and study plan

metformin

Drug

1000 mg dose of immediate-release metformin

CIN-107

Drug

10 mg dose of CIN-107

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Up to day 3

    This plasma PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites.

  2. Time to Cmax (Tmax)

    Time frame: Up to day 3

    This plasma PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites.

  3. Area under the concentration-time curve (AUC) from time 0 to 72 hours

    Time frame: Up to day 3

    This plasma PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites.

  4. Maximum plasma concentration (Cmax) of metformin

    Time frame: Up to day 3

    This plasma PK parameter will be determined for metformin.

  5. Time to Cmax (Tmax) of metformin

    Time frame: Up to day 3

    This plasma PK parameter will be determined for metformin.

  6. AUC from time 0 to the time of last quantifiable plasma concentration of metformin

    Time frame: Up to day 3

    This plasma PK parameter will be determined for metformin.

  7. AUC from time 0 to infinity of metformin

    Time frame: Up to day 3

    This plasma PK parameter will be determined for metformin.

  8. Percent of AUC extrapolated of metformin

    Time frame: Up to day 3

    This plasma PK parameter will be determined for metformin.

  9. Terminal phase elimination half-life of metformin

    Time frame: Up to day 3

    This plasma PK parameter will be determined for metformin.

  10. Cumulative amount of metformin excreted in the urine (Ae) of metformin

    Time frame: Up to day 3

    This urine PK parameter will be determined for metformin.

  11. Renal clearance (calculated as Ae/AUC) of metformin

    Time frame: Up to day 3

    This urine PK parameter will be determined for metformin.

  12. Fraction of the dose excreted renally of metformin

    Time frame: Up to day 3

    This urine PK parameter will be determined for metformin.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Open-Label, Two-Period, Crossover Study to Evaluate the Effect of CIN-107 on the Pharmacokinetics of the MATE Substrate, Metformin, in Healthy Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 2, 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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