← Back to Search

THRV-1268 for Atrial Fibrillation

Phase 1
Recruiting
Research Sponsored by Thryv Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects must meet contraceptive criteria or be postmenopausal or surgically sterile
Aged 18 to 60 years with BMI within 18.5 to 30.0 kg/m2
Must not have
Lactating females
Male subjects with reproductive disorders or undergoing infertility treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sad: day 7; food effect: day 15; mad: day 16

Summary

This trial will be conducted at one location and will involve giving participants different doses of a drug while keeping some participants on a placebo. The study will have two parts: one part where participants will receive a

Who is the study for?
This trial is for individuals with atrial fibrillation, a heart condition causing irregular heartbeat. Participants will be screened within 28 days before joining the study to ensure they meet specific health requirements.
What is being tested?
The study tests THRV-1268 against a placebo in two parts: one where participants take a single dose and another where they take multiple doses. The effects of food on the drug are also being studied.
What are the potential side effects?
Since this summary does not provide details on side effects, it's important to note that common side effects may include reactions at the injection site, nausea, headache, or other symptoms as determined by further research.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am using birth control, am postmenopausal, or have been surgically sterilized.
Select...
I am between 18 and 60 years old with a BMI between 18.5 and 30.
Select...
I am a healthy adult.
Select...
I am a man who can father children and agree to use contraception and not donate sperm.
Select...
I have no significant health issues apart from my current condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently breastfeeding.
Select...
I am a male with fertility issues or currently receiving infertility treatment.
Select...
I am not currently using immunosuppressants, have not had major surgery recently, and do not have a drug dependency.
Select...
My kidney function is reduced with a creatinine clearance below 80 mL/min.
Select...
I have a history of heart or blood vessel conditions.
Select...
I have had tuberculosis in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sad: day 7; food effect: day 15; mad: day 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and sad: day 7; food effect: day 15; mad: day 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability: Number of Participants with Adverse Events
Secondary study objectives
Pharmacokinetic LQT-1268 AUC0-t
Pharmacokinetic LQT-1268 Cmax
Pharmacokinetic LQT-1268 Tmax
+7 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Single Ascending Dose (SAD) THRV-1268Experimental Treatment1 Intervention
5 dosing cohorts will receive a single oral dose of THRV-1268. The highest dose of THRV-1268 to be administered is 500 mg.
Group II: Multiple Ascending Dose (MAD) THRV-1268Experimental Treatment1 Intervention
3 dosing cohorts will receive THRV-1268 in the morning on Day 1 to Day 7.
Group III: Food Effect THRV-1268Experimental Treatment1 Intervention
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.
Group IV: Single Ascending Dose (SAD) PlaceboPlacebo Group1 Intervention
5 dosing cohorts will receive a single oral dose of placebo.
Group V: Food Effect PlaceboPlacebo Group1 Intervention
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.
Group VI: Multiple Ascending Dose (MAD) PlaceboPlacebo Group1 Intervention
3 dosing cohorts will receive placebo in the morning from Day 1 to Day 7.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Thryv Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
78 Total Patients Enrolled
~32 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top