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Completed

NCT Number: NCT05497674

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Hospital of Jilin University

Jilin City, Changchun, 130000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rongliflozin

Drug

oral administration, single dose on Day 1 and Day 11

Rifampin

Drug

QD for 10 days

Probenecid

Drug

twice a day, for 5 days

Primary outcomes

  1. rongliflozin: area under the drug-time curve (AUC) ratios of geometric means of rongliflozin+rifampicin relative to rongliflozin alone.

    Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing

    To assess the effect of rifampicin on the AUC of rongliflozin

  2. rongliflozin: The peak concentration (Cmax) ratios of geometric means of rongliflozin+rifampicin relative to rongliflozin alone.

    Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing

    To assess the effect of rifampicin on the Cmax of rongliflozin

  3. rongliflozin: AUC ratios of geometric means of rongliflozin+probenecid relative to rongliflozin alone.

    Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing

    To assess the effect of probenecid on the AUC of rongliflozin

  4. rongliflozin:Cmax ratios of geometric means of rongliflozin+probenecid relative to rongliflozin alone.

    Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing

    To assess the effect of probenecid on the Cmax of rongliflozin

Secondary outcomes

  1. The time to peak (Tmax) of Rongliflozin.

    Time frame: from 0 hour(pre-dose,within 30mins)to 5 days after rongliflozin dosing

    To assess the effect of rifampicin and probenecid on the Tmax of rongliflozin

  2. pharmacology (PD) of rongliflozin: cumulative urine glucose excretion every 24 hours

    Time frame: from 0 hour to 5 days after rongliflozin dosing

    evaluate the cumulative urine glucose excretion every 24 hours after rongliflozin administration.

  3. the number of participants with adverse events (AE) in Cohort A

    Time frame: from screening to 3 days after last dose of rifampicin

    To evaluate the safety and tolerability of single dose of rongliflozin and combination of rifampin

  4. the number of participants with adverse events (AE) in Cohort B

    Time frame: from screening to 3 days after last dose of probenecid

    To evaluate the safety and tolerability of single dose of rongliflozin and combination of probenecid

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

A Study In Healthy Subjects To Assess The Effects Of Rifampicin Capsules and Probenecid Tablets On The Pharmacokinetic Profile Of Rongliflozin Capsules

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 11, 2022
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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