Drug-durg Interaction of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin

NCT07362030 | Active Not Recruiting Phase 1

• 1 other identifier: RAY1225-24-11
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The drug-drug interaction study had been designed to investigate the effect of RAY1225 on the pharmacokinetics of digoxin, Rosuvastatin and

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic - Cmax

  Maximum observed plasma concentration

  Day 1~Day 5 and Day 86~Day 107

• Pharmacokinetic -Area under the curve（AUC）

  Area under the curve

  Day 1~Day 5 and Day 86~Day 107

Secondary Outcomes (1)

• Number of participants with adverse events

  DAY 1~Day 107

Study Arms (1)

Experimental 1

EXPERIMENTAL

Period 1: All participants took one tablet of atorvastatin calcium (20mg) and one tablet of metformin hydrochloride (500mg) in the morning of Day 1, after fasting. On the morning of Day 8, they took two tablets of warfarin sodium (5mg) and one tablet of digoxin (0.25mg) in the same fasting condition. Period 2: All participants were injected with RAY1225 once every two weeks (a total of 7 times, with each dose ranging from 1mg to 3mg to 6mg to 6mg to 6mg to 6mg to 6mg). On D86 (24±1 hours after the 6th administration of RAY1225), they took 1 tablet of atorvastatin calcium (20mg) and 1 tablet of metformin hydrochloride (500mg) orally in an empty stomach condition with approximately 240ml of warm water. On D100 (24±1 hours after the 7th administration of RAY1225), they took 2 tablets of warfarin sodium (5mg) and 1 tablet of digoxin (0.25mg) orally in an empty stomach condition with approximately 240ml of warm water in the morning.

Drug: RAY1225; Drug: atorvastatin calcium tablet; Drug: Metformin Tablets; Drug: Warfarin Sodium Tablets; Drug: Digoxin Tablets

Interventions

RAY1225 DRUG

subcutaneous injection

Experimental 1

atorvastatin calcium tablet DRUG

Oral

Experimental 1

Metformin Tablets DRUG

Oral

Experimental 1

Warfarin Sodium Tablets DRUG

Oral

Experimental 1

Digoxin Tablets DRUG

Oral

Experimental 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) ≥20 to ≤35 kg/m2 and total body weight \>50 kg(male) or \>45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
• Ability to understand and willingness to sign a written informed consent form;
• Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

You may not qualify if:

• Participants with a history of hypersensitivity to study drug or any component of study medication;
• Participants had taken prescription, over-the-counter, herbal, or vitamin products within 4 weeks prior to screening；
• Smoking more than 5 cigarettes per day within 12 weeks prior to screening，or who cannot stop using any tobacco products during the study period;
• Participants who donated blood/bleeding profusely (\> 400 mL) 12 weeks prior to randomization;
• Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF \> 450ms;
• Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
• Females who are pregnant, lactating, or likely to become pregnant during the study.
• History of dysphagia or any gastrointestinal disorder that affect absorption

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Dongguan People's Hospital

Dongguan, China

Location

MeSH Terms

Conditions

Obesity

Interventions

Atorvastatin; Metformin; Warfarin; Digoxin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Biguanides; Guanidines; Amidines; Organic Chemicals; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 23, 2026
• Study Start: April 14, 2025
• Primary Completion: December 27, 2025
• Study Completion: March 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CN (1)