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

A Open-Label, Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin in Healthy Participants

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

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: RAY1225; Drug: atorvastatin calcium tablet; Drug: Metformin Tablets; Drug: Warfarin Sodium Tablets; Drug: Digoxin Tablets

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Dongguan, China
    • Dongguan People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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);
2. Ability to understand and willingness to sign a written informed consent form;
3. Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion Criteria:

1. Participants with a history of hypersensitivity to study drug or any component of study medication;
2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 4 weeks prior to screening；
3. 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;
4. Participants who donated blood/bleeding profusely (> 400 mL) 12 weeks prior to randomization;
5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
6. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
7. Females who are pregnant, lactating, or likely to become pregnant during the study.
8. History of dysphagia or any gastrointestinal disorder that affect absorption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental 1; 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; subcutaneous injection; Drug: atorvastatin calcium tablet; Oral; Drug: Metformin Tablets; Oral; Drug: Warfarin Sodium Tablets; Oral; Drug: Digoxin Tablets; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	The safety and tolerability of RAY1225 alone and in combination with IWarfarin, atorvastatin, metformin and digoxin will be examined.	DAY 1~Day 107

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Actual): December 27, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Fatty Acids; Lipids; Azoles; Carbohydrates; Polycyclic Compounds; Glycosides; Steroids; Fused-Ring Compounds; Pyrroles; Heptanoic Acids; Biguanides; Guanidines; Amidines; Coumarins; Benzopyrans; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; 4-Hydroxycoumarins; Atorvastatin; Digoxin; Metformin; Warfarin
• Other Study ID Numbers: RAY1225-24-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No