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

NCT ID: NCT05497674

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2023-02-24

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

rongliflozin and/or rifampicin

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.

Group Type: EXPERIMENTAL

Rongliflozin

Intervention Type: DRUG

oral administration, single dose on Day 1 and Day 11

Rifampin

Intervention Type: DRUG

QD for 10 days

rongliflozin and/or probenecid

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.

Group Type: EXPERIMENTAL

Rongliflozin

Intervention Type: DRUG

oral administration, single dose on Day 1 and Day 6

Probenecid

Intervention Type: DRUG

twice a day, for 5 days

Interventions

Rongliflozin

oral administration, single dose on Day 1 and Day 11

Intervention Type: DRUG

Rifampin

QD for 10 days

Intervention Type: DRUG

Rongliflozin

oral administration, single dose on Day 1 and Day 6

Intervention Type: DRUG

Probenecid

twice a day, for 5 days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Hospital of Jilin University

Jilin, Changchun, China

Countries

China

Other Identifiers

DJT1116PG-DM-108

Identifier Type: -

Identifier Source: org_study_id