RECRUITING

Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, PK, PD, and Comparative Bioavailability of THRV-1268 in Obese Adult Participants

Conditions

Heart Failure obesity cardiometabolic atrial fibrillation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A research study that involves the use of an investigational drug called THRV-1268. The main purpose is to measure the safety (whether it causes any side effects) and tolerability (if it does cause any side effects, how well your body is able to handle them) in healthy obese adults. This study will also look at how the drug moves through the body, is absorbed, distributed, metabolized and eliminated.

Official Title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Comparative Bioavailability (Unblinded) of THRV-1268 in Health Obese Adult Participants

Quick Facts

Study Start:2025-09-15

Study Completion:2025-10-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07186946

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. Clinically significant cardiovascular, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, or psychiatric disease, or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2. Female who is lactating. 3. Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration. 4. Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system. 5. Male subjects who are undergoing treatment or evaluation for infertility. 6. The average of 3 BP measurements performed approximately 5 min apart: Screening or baseline (Day -1, Period 1) diastolic BP \<50 mmHg or \>95; systolic BP \<100 mmHg or \>145 mmHg; or HR ≤ 50 beats per minute (bpm) using a validated digital BP device. These can be repeated in triplicate once after an additional quiet resting period. 7. Orthostatic BP performed after at least 5 mins in supine position, and then after standing for at least 2 minutes but no more than 3 minutes with a reduction in systolic BP \>20 mmHg, a reduction in diastolic BP \>10 mmHg, or an increase in HR \>20 bpm using a validated digital BP device. 8. History of significant hypersensitivity to THRV-1268, kinase inhibitors or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs. 9. Screening and check-in Period 1: 12-lead ECG demonstrating at least one of the following: PR \>220 ms; QRS \>110 ms, or QTcF \>450 ms in males and 470 ms in females; atrioventricular block; branch bundle block, significant ST-T wave abnormalities or flat T waves that could interfere with QT analysis. Heart rate ≤50 bpm or \>100 bpm. 10. History or evidence of any of the following: myocardial infarction; cardiac valvulopathy; cardiac surgery revascularization (coronary artery bypass grafting or percutaneous, transluminal coronary angioplasty); unstable angina; cerebrovascular accident, stroke, or transient ischemic attack; pacemaker; AF, flutter, or nonsustained or sustained ventricular tachycardia; orthostatic hypotension or orthostatic dizziness or lightheadedness, pulmonary arterial hypertension; sick sinus syndrome, second- or third-degree atrioventricular block; uncontrolled hypertension; congestive heart failure; personal or family history of sudden death or long QT syndrome; unexplained syncope or syncope within the last 3 years regardless of etiology. 11. Immunization with a Coronavirus Disease (COVID-19) vaccine in the 14 days prior to the first study drug administration. 12. Scheduled immunization with a COVID-19 vaccine during the study that, in the opinion of an Investigator, could potentially interfere with subject participation, subject safety, study results, or any other reason. 13. Use of immunosuppressant in the 28 days or 5 half-lives (whichever is longer) prior to the first study drug administration. 14. Major surgery with prolonged immobilization in the 28 days prior to the first study drug administration. 15. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic). 16. Any clinically significant illness in the 28 days prior to the first study drug administration. 17. Use of any over-the-counter or nutritional supplements in the last 7 days prior to the first study drug administration and during the study, that in the opinion of an Investigator would put into question the status of the subject as healthy. 18. Use of any prescription drugs (except for hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an Investigator would put into question the status of the subject as healthy. 19. Use of St. John's wort in the 28 days prior to the first study drug administration. 20. Any history of tuberculosis. 21. Hemoglobin value below the lower limit of the reference laboratory at Screening, unless deemed non-significant by the Investigator. 22. Abnormal screening values in potassium, magnesium, alanine transaminase (ALT), aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, total bilirubin, and direct bilirubin values, unless deemed non-significant by the Investigator. 23. Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration. 24. Current or history of alcohol or substance abuse, with the exception of being fully recovered with no use of alcohol or substances of abuse within the 12 months prior to Screening 25. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus antibody tests. 26. Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data. 27. History of prior administration of THRV-1268 or inclusion in a previous cohort for this clinical study. 28. Treatment with any investigational product within 30 days or five half-lives of the drug (whichever is longer) prior to Screening 29. Unable or unwilling to adhere to the lifestyle and dietary requirements described in Section 5.5. 30. Special diet or substantial changes in eating habits in the last 1 month before Screening. 31. Donation of 500 mL or more of blood (blood services, clinical studies, etc.) in the 56 days prior to Screening or donation of plasma within 7 days prior to Screening

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. Clinically significant cardiovascular, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, or psychiatric disease, or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
2. Female who is lactating.
3. Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration.
4. Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system.
5. Male subjects who are undergoing treatment or evaluation for infertility.
6. The average of 3 BP measurements performed approximately 5 min apart: Screening or baseline (Day -1, Period 1) diastolic BP \<50 mmHg or \>95; systolic BP \<100 mmHg or \>145 mmHg; or HR ≤ 50 beats per minute (bpm) using a validated digital BP device. These can be repeated in triplicate once after an additional quiet resting period.
7. Orthostatic BP performed after at least 5 mins in supine position, and then after standing for at least 2 minutes but no more than 3 minutes with a reduction in systolic BP \>20 mmHg, a reduction in diastolic BP \>10 mmHg, or an increase in HR \>20 bpm using a validated digital BP device.
8. History of significant hypersensitivity to THRV-1268, kinase inhibitors or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
9. Screening and check-in Period 1: 12-lead ECG demonstrating at least one of the following: PR \>220 ms; QRS \>110 ms, or QTcF \>450 ms in males and 470 ms in females; atrioventricular block; branch bundle block, significant ST-T wave abnormalities or flat T waves that could interfere with QT analysis. Heart rate ≤50 bpm or \>100 bpm.
10. History or evidence of any of the following: myocardial infarction; cardiac valvulopathy; cardiac surgery revascularization (coronary artery bypass grafting or percutaneous, transluminal coronary angioplasty); unstable angina; cerebrovascular accident, stroke, or transient ischemic attack; pacemaker; AF, flutter, or nonsustained or sustained ventricular tachycardia; orthostatic hypotension or orthostatic dizziness or lightheadedness, pulmonary arterial hypertension; sick sinus syndrome, second- or third-degree atrioventricular block; uncontrolled hypertension; congestive heart failure; personal or family history of sudden death or long QT syndrome; unexplained syncope or syncope within the last 3 years regardless of etiology.
11. Immunization with a Coronavirus Disease (COVID-19) vaccine in the 14 days prior to the first study drug administration.
12. Scheduled immunization with a COVID-19 vaccine during the study that, in the opinion of an Investigator, could potentially interfere with subject participation, subject safety, study results, or any other reason.
13. Use of immunosuppressant in the 28 days or 5 half-lives (whichever is longer) prior to the first study drug administration.
14. Major surgery with prolonged immobilization in the 28 days prior to the first study drug administration.
15. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
16. Any clinically significant illness in the 28 days prior to the first study drug administration.
17. Use of any over-the-counter or nutritional supplements in the last 7 days prior to the first study drug administration and during the study, that in the opinion of an Investigator would put into question the status of the subject as healthy.
18. Use of any prescription drugs (except for hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an Investigator would put into question the status of the subject as healthy.
19. Use of St. John's wort in the 28 days prior to the first study drug administration.
20. Any history of tuberculosis.
21. Hemoglobin value below the lower limit of the reference laboratory at Screening, unless deemed non-significant by the Investigator.
22. Abnormal screening values in potassium, magnesium, alanine transaminase (ALT), aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, total bilirubin, and direct bilirubin values, unless deemed non-significant by the Investigator.
23. Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration.
24. Current or history of alcohol or substance abuse, with the exception of being fully recovered with no use of alcohol or substances of abuse within the 12 months prior to Screening
25. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus antibody tests.
26. Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
27. History of prior administration of THRV-1268 or inclusion in a previous cohort for this clinical study.
28. Treatment with any investigational product within 30 days or five half-lives of the drug (whichever is longer) prior to Screening
29. Unable or unwilling to adhere to the lifestyle and dietary requirements described in Section 5.5.
30. Special diet or substantial changes in eating habits in the last 1 month before Screening.
31. Donation of 500 mL or more of blood (blood services, clinical studies, etc.) in the 56 days prior to Screening or donation of plasma within 7 days prior to Screening

Contacts and Locations

Study Locations (Sites)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212

United States

Collaborators and Investigators

Sponsor: Thryv Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15

Study Completion Date2025-10-14

Study Record Updates

Study Start Date2025-09-15

Study Completion Date2025-10-14

Terms related to this study

Keywords Provided by Researchers

heart failure
obesity
cardiometabolic
atrial fibrillation

Additional Relevant MeSH Terms

Heart Failure