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

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Drug: THRV-1268; Drug: Placebo

• Registration Number: NCT07186946
• Lead Sponsor: Thryv Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-15
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-23
• Primary Completion: 2025-10-14
• Study Completion: 2025-10-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose (SAD) THRV-1268 low dose (100mg)	THRV-1268	In Period 1 of cohort 1 will receive a single oral dose of THRV-1268 100mg
Single Ascending Dose (SAD) THRV-1268 low dose (100mg)	Placebo	In Period 1 of cohort 1 will receive a single oral dose of THRV-1268 100mg
THRVY-1268 high dose (200mg)	THRV-1268	In cohort 2, will receive a single oral dose of THRV-1268 200mg
THRVY-1268 high dose (200mg)	Placebo	In cohort 2, will receive a single oral dose of THRV-1268 200mg

Primary Outcome Measures

Name	Time	Method
Evalute the safety and tolerability of a single oral dose	7 days	-Occurance of treatment emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic THRV-1268 Tmax	From 0 to 24 hours	Time to maximum observed plasma drug concentration
Pharmacokinetic THRV-1268 t1/2	From 0 to 24 hours	half-life
Pharmacokinetic THRV-1268 Cmax	From 0 to 24 hours	Maximum observed plasma drug concentration
Pharmacokinetic THRV-1268 AUC0-t	From 0 to 24 hours	Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable concentration
Evaluate and compare the bioavailability	From 0 to 24 hours	To evaluate the relative bioavailability (Area under the plasma concentration versus time curve (AUC)) of THRV-1268 tablet relative to THRV-1268 API powder for oral

Trial Locations

Locations (1)

Dr. Vince Clinical Research; 🇺🇸 Overland Park, Kansas, United States