Atrial FibrillationPhase 1NCT06507839
Study to Assess the Safety, Tolerability, Pharmacokinetic of Thrv-1268
A Phase 1 study testing THRV-1268 in people with Atrial Fibrillation, run by Thryv Therapeutics, Inc. at 1 site in Canada.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- THRV-1268
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2024to 1 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Provision of signed and dated Informed Consent Form (ICF). 2.Stated willingness to comply with all study procedures and availability for the duration of the study.
- 3.Healthy adult male or female subjects. 4.If female, meets one of the following criteria:
- Women of childbearing potential who agrees to use any of the acceptable contraceptive methods:
- Abstinence from heterosexual intercourse from Screening through at least 30 days from last study dose.
- One of the following highly-effective contraception methods:
- systemic contraceptives (combined birth control pills, injectable/implant/ insertable hormonal birth control products, or transdermal patch) used from at least 28 days prior to Screening through to at least 30 days from last study dose
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- intrauterine device (with or without hormones) used from at least 28 days prior to Screening through to at least 30 days from last study dose
- male partner vasectomized at least 6 months prior to Screening visit
- One of the following double-barrier contraception methods used from Screening through at least 30 days from last study dose
- Male condom used simultaneously with diaphragm plus spermicide
- Male condom used simultaneously with cervical cap plus spermicide Or
- Physiological postmenopausal status, defined as the absence of menses for at least 12 months following cessation of all exogenous hormonal treatments (without an alternative medical condition) at Screening and prior to the first study drug administration and have follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at Screening (If subject is postmenopausal and has an FSH of < 40 mIU/mL, but meets all other criteria in (1) or (2) above as well as all the other inclusion criteria, screening estradiol serum level must be equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, eligibility for study participation will be based on medical judgment.).
- Or
- Surgically sterile, defined as those who have had hysterectomy, bilateral oophorectomy and/or bilateral salpingectomy, or bilateral tubal ligation.
- 5.Men who are biologically capable of fathering children must agree and commit to use an adequate form of contraception (see female criteria 3) for the duration of the treatment period and for no less than 90 days after the last study dose. A male subject is considered capable of fathering children even if his sexual partner is sterile or using contraceptives.
- 6.Men who are biologically capable of fathering children must also agree to refrain from sperm donation for the duration of the treatment period and for at least 90 days after the last study dose.
- 7.Aged at least 18 years but not older than 60 years (inclusive). 8.Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively. 9.Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration).
- 10.Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings in the physical examination (including vital signs) and/or ECG, as determined by an Investigator.
Who cannot join
- Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular 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.
- Clinically significant abnormal findings on the physical examination or medical history during Screening as deemed by the Investigator.
- Female who is lactating.
- Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration.
- Male subjects with a history of oligospermia or azoospermia or any other disorder of the reproductive system.
- Male subjects who are undergoing treatment or evaluation for infertility.
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- The average of 3 measurements performed approximately 5 min apart: Screening or baseline (Day -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.
- Orthostatic BP performed after sitting quietly for at least 4 minutes and then standing for 2 minutes with a duplicate set performed after at least 3 minutes of sitting, 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.
- Estimated creatinine clearance < 80 mL/min at Screening.
- 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.
- Screening 12-lead ECG demonstrating at least one of the following: PR >220 ms; QRS >110 ms, or QTcF >440 ms; 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.
- 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.
- Immunization with a Coronavirus Disease (COVID-19) vaccine in the 14 days prior to the first study drug administration.
- 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.
- Use of immunosuppressant in the 28 days or 5 half-lives (whichever is longer) prior to the first study drug administration.
- Major surgery with prolonged immobilization in the 28 days prior to the first study drug administration.
- 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).
- Any clinically significant illness in the 28 days prior to the first study drug administration.
- 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.
- 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.
- Use of St. John's wort in the 28 days prior to the first study drug administration.
- Any history of tuberculosis.
- Hemoglobin value below the lower limit of the reference laboratory at Screening, unless deemed non-significant by the Investigator.
- 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.
- Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration.
- Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus antibody tests.
- 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.
- History of prior administration of THRV-1268 or inclusion in a previous cohort for this clinical study.
- Intake of an IP or participation in a clinical trial in the 28 days or 5 half-lives (whichever is longer) prior to the first study drug administration.
- Unable or unwilling to adhere to the lifestyle and dietary requirements described in Section 4.4.
- Special diet or substantial changes in eating habits in the last 1 month before Screening.
- Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration.
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study To Assess the Safety, Tolerability, Pharmacokinetics, and Food Effect of Thrv-1268 in Healthy Adult Subjects
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.
- Conditions
- Atrial Fibrillation
- Being tested
- THRV-1268, Placebo
- Keywords
- THRV-1268, Atrial Fibrillation, Serum glucocorticoid regulated kinase-1, SGK-1 inhibitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRV-1268Drug
THRV-1268 a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) THRV-1268 | Experimental | 5 dosing cohorts will receive a single oral dose of THRV-1268. The highest dose of THRV-1268 to be administered is 500 mg. Receives: Drug: THRV-1268 |
| Food Effect THRV-1268 | Experimental | food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort. Receives: Drug: THRV-1268 |
| Multiple Ascending Dose (MAD) THRV-1268 | Experimental | 3 dosing cohorts will receive THRV-1268 in the morning on Day 1 to Day 7. Receives: Drug: THRV-1268 |
| Single Ascending Dose (SAD) Placebo | Placebo comparator | 5 dosing cohorts will receive a single oral dose of placebo. Receives: Other: Placebo |
| Food Effect Placebo | Placebo comparator | Food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort. Receives: Other: Placebo |
| Multiple Ascending Dose (MAD) Placebo | Placebo comparator | 3 dosing cohorts will receive placebo in the morning from Day 1 to Day 7. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Number of Participants with Adverse Events
Number of Participants with Adverse Events
Measured: SAD: Day 7; Food Effect: Day 15; MAD: Day 16
Secondary outcomes (10)
Pharmacokinetic LQT-1268 AUC0-t
Area under the concentration-time curve (AUC) from time 0 to the time of the last
Measured: SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7
Pharmacokinetic LQT-1268 Cmax
Maximum observed plasma drug concentration
Measured: SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7
Pharmacokinetic LQT-1268 Tmax
Time to maximum observed plasma drug concentration
Measured: SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7
Pharmacokinetic LQT-1268 t1/2
Time to maximum observed plasma drug concentration
Measured: SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7
Urine Pharmacokinetics of LQT-1268: Ae
Amount of the administered dose recovered over the entire 24-hour interval
Measured: SAD: Day 1; MAD: Serially on Day 1 and 7
Urine Pharmacokinetics of LQT-1268: Fe
Percentage of the administered dose recovered over the entire 24-hour interval
Measured: SAD: Day 1; MAD: Serially on Day 1 and 7
Urine Pharmacokinetics of LQT-1268: Ae0-t
Amount excreted unchanged in urine over a given time interval
Measured: SAD: Day 1; MAD: Serially on Day 1 and 7
Plasma Pharmacokinetics of LQT-1268: Ctrough
Concentration of drug in the blood immediately before the next dose is administered
Measured: MAD: Days 3-6
Plasma Pharmacokinetics of LQT-1268: Rac(AUC)
Drug accumulation ratio
Measured: MAD: Day 7
Plasma Pharmacokinetics of LQT-1268: Rac(Cmax)
Drug accumulation ratio
Measured: MAD: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start15 May 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thryv Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507839
- Sponsor's protocol ID
- 0269
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study To Assess the Safety, Tolerability, Pharmacokinetics, and Food Effect of Thrv-1268 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06507839
- Acronym / sponsor ID
- 0269
- Conditions
- Atrial Fibrillation
- Keywords
- THRV-1268, Atrial Fibrillation, Serum glucocorticoid regulated kinase-1, SGK-1 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Thryv Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) THRV-1268 | Experimental | Drug: THRV-12685 dosing cohorts will receive a single oral dose of THRV-1268. The highest dose of THRV-1268 to be administered is 500 mg. |
| Food Effect THRV-1268 | Experimental | Drug: THRV-1268food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort. |
| Multiple Ascending Dose (MAD) THRV-1268 | Experimental | Drug: THRV-12683 dosing cohorts will receive THRV-1268 in the morning on Day 1 to Day 7. |
| Single Ascending Dose (SAD) Placebo | Placebo comparator | Other: Placebo5 dosing cohorts will receive a single oral dose of placebo. |
| Food Effect Placebo | Placebo comparator | Other: PlaceboFood effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort. |
| Multiple Ascending Dose (MAD) Placebo | Placebo comparator | Other: Placebo3 dosing cohorts will receive placebo in the morning from Day 1 to Day 7. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 1.Provision of signed and dated Informed Consent Form (ICF). 2.Stated willingness to comply with all study procedures and availability for the duration of the study.
- 3.Healthy adult male or female subjects. 4.If female, meets one of the following criteria:
- Women of childbearing potential who agrees to use any of the acceptable contraceptive methods:
- Physiological postmenopausal status, defined as the absence of menses for at least 12 months following cessation of all exogenous hormonal treatments (without an alternative medical condition) at Screening and prior to the first study drug administration and have follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at Screening (If subject is postmenopausal and has an FSH of < 40 mIU/mL, but meets all other criteria in (1) or (2) above as well as all the other inclusion criteria, screening estradiol serum level must be equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, eligibility for study participation will be based on medical judgment.).
- Or
Key exclusion criteria (33 listed)
- Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular 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.
- Clinically significant abnormal findings on the physical examination or medical history during Screening as deemed by the Investigator.
- Female who is lactating.
- Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration.
- Male subjects with a history of oligospermia or azoospermia or any other disorder of the reproductive system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRV-1268THRV-1268 a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor | Drug | Food Effect THRV-1268, Multiple Ascending Dose (MAD) THRV-1268, Single Ascending Dose (SAD) THRV-1268 |
| PlaceboMatching placebo | Other | Food Effect Placebo, Multiple Ascending Dose (MAD) Placebo, Single Ascending Dose (SAD) Placebo |
Primary outcome
Safety and Tolerability: Number of Participants with Adverse Events
Time frame: SAD: Day 7; Food Effect: Day 15; MAD: Day 16
Number of Participants with Adverse Events
10 secondary outcomes
Pharmacokinetic LQT-1268 AUC0-t
Time frame: SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7
Pharmacokinetic LQT-1268 Cmax
Time frame: SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7
Pharmacokinetic LQT-1268 Tmax
Time frame: SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7
Pharmacokinetic LQT-1268 t1/2
Time frame: SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7
Urine Pharmacokinetics of LQT-1268: Ae
Time frame: SAD: Day 1; MAD: Serially on Day 1 and 7
Urine Pharmacokinetics of LQT-1268: Fe
Time frame: SAD: Day 1; MAD: Serially on Day 1 and 7
Urine Pharmacokinetics of LQT-1268: Ae0-t
Time frame: SAD: Day 1; MAD: Serially on Day 1 and 7
Plasma Pharmacokinetics of LQT-1268: Ctrough
Time frame: MAD: Days 3-6
Plasma Pharmacokinetics of LQT-1268: Rac(AUC)
Time frame: MAD: Day 7
Plasma Pharmacokinetics of LQT-1268: Rac(Cmax)
Time frame: MAD: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THRV-1268 in people with Atrial Fibrillation, run by Thryv Therapeutics, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability: Number of Participants with Adverse Events (time frame: SAD: Day 7; Food Effect: Day 15; MAD: Day 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.