Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Rongliflozin; Drug: Rifampin; Drug: Probenecid

Study type: Interventional

Funder types: Industry

Identifiers

NCT05497674

DJT1116PG-DM-108

Details and patient eligibility

About

This is a phase I, open-label, fixed-sequence study in healthy Chinese subjects, performed at a single study centre. Cohort A will assess the Pharmacokinetic (PK) profile of rongliflozin when administered alone and the combination with rifampicin; Cohort B will assess the PK profile of rongliflozin when administered alone and combination with probenecid.

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Sign the informed consent form before the trial and fully understand the trial content, process and possible adverse reactions;
• Be able to complete the test according to the requirements of the protocol;
• Subjects (including partners) are willing to take effective contraceptive measures from screening to 6 months after the last dose of drug administration;
• Male subjects weigh at least 50 kg and female subjects at least 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI within the range of 18 to 28 kg/m2 ;
• Physical examination and vital signs are both normal or do not have clinical significance.

Exclusion criteria

• Smoking more than 5 cigarettes per day;
• Those who are allergic to or have allergies to the test drug;
• have a history of drug or alcohol abuse;
• Blood donation or massive blood loss (>450 mL) within three months prior to screening;
• Difficulty swallowing or any history of digestive system diseases which could affect drug absorption and excretion within 6 months before screening;
• taking any drugs that could alter liver enzyme activity, such as barbiturates, rifampin, etc., within 30 days before screening;
• have taken any prescription, over-the-counter, vitamin product or herbal medicine within 14 days prior to screening;
• Have taken special diets (including dragon fruit, mango, grapefruit, etc.) or exercised strenuously within 2 weeks before screening;
• Take an inhibitor or inducer of glucuronide transferase (UGT), P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP), such as itraconazole, ketoconazole, or dronedarone, within 30 days before screening;
• Significant changes in dietary or exercise habits within 2 weeks prior to screening; Female subjects are breastfeeding or have a positive blood pregnancy result during the screening period;
• During the screening period, the serum uric acid level was >420 µmol/l, or had a history of gout; during the screening period, the estimated glomerular filtration rate (eGFR) was <90 ml/min/1.73m2) or had a history of kidney stones or bladder stones (applicable to Cohort B);
• have a clinically significant laboratory tests or medical history;
• Positive for hepatitis B, hepatitis C, AIDS, syphilis; positive for urine drug test;
• History of urinary tract infection or genital infection before 6 months
• Those who participated in any drug clinical trial and used the experimental drug 3 months ago;
• Subjects with other factors deemed inappropriate by the investigator.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

rongliflozin and/or rifampicin

Experimental group

Description:

on Day 1, subjects will receive a single dose administration of rongliflozin, followed by a washout period of 4 days. Starting On Day 5, subjects will administer rifampicin once a day (QD) for 10 consecutive days ( Day 5 to Study Day 14) , comprising of a single dose administration of rongliflozin on Study Day 11.

Treatment:

Drug: Rifampin

Drug: Rongliflozin

rongliflozin and/or probenecid

Experimental group

Description:

on Day 1, subjects will receive a single dose administration of rongliflozin, followed by a washout period of 4 days. Probenecid will be administrated twice a day from Day 5 to Day 9, and another single dose administration of rongliflozin on Day 6.

Treatment:

Drug: Probenecid

Drug: Rongliflozin