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

Guangdong Raynovent Biotech

Status and phase: Active, not recruiting; Phase 1

Conditions: Obesity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07362030

RAY1225-24-11

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Experimental 1

Experimental group

Description:

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.

Treatment:

Drug: Digoxin Tablets

Drug: RAY1225

Drug: atorvastatin calcium tablet

Drug: Metformin Tablets

Drug: Warfarin Sodium Tablets