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

S

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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