Type 2 Diabetes MellitusPhase 1NCT05497674
Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects
A Phase 1 study testing Rongliflozin, Rifampin and Probenecid in people with Type 2 Diabetes Mellitus, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Rongliflozin, Rifampin and Probenecid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2022to 24 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Jilin University
Jilin City, Changchun, 130000
About this study
Official title: A Study In Healthy Subjects To Assess The Effects Of Rifampicin Capsules and Probenecid Tablets On The Pharmacokinetic Profile Of Rongliflozin Capsules
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
- Being tested
- Rongliflozin, Rifampin, Probenecid
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RongliflozinDrug
oral administration, single dose on Day 1 and Day 11
RifampinDrug
QD for 10 days
RongliflozinDrug
oral administration, single dose on Day 1 and Day 6
ProbenecidDrug
twice a day, for 5 days
| Study group | Role | What they receive |
|---|---|---|
| rongliflozin and/or rifampicin | Experimental | 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. Receives: Drug: Rongliflozin; Drug: Rifampin |
| rongliflozin and/or probenecid | Experimental | 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. Receives: Drug: Rongliflozin; Drug: Probenecid |
What is being measured
The primary outcome is the main question the study is designed to answer.
rongliflozin: area under the drug-time curve (AUC) ratios of geometric means of rongliflozin+rifampicin relative to rongliflozin alone.
To assess the effect of rifampicin on the AUC of rongliflozin
Measured: from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing
rongliflozin: The peak concentration (Cmax) ratios of geometric means of rongliflozin+rifampicin relative to rongliflozin alone.
To assess the effect of rifampicin on the Cmax of rongliflozin
Measured: from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing
rongliflozin: AUC ratios of geometric means of rongliflozin+probenecid relative to rongliflozin alone.
To assess the effect of probenecid on the AUC of rongliflozin
Measured: from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing
rongliflozin:Cmax ratios of geometric means of rongliflozin+probenecid relative to rongliflozin alone.
To assess the effect of probenecid on the Cmax of rongliflozin
Measured: from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing
Secondary outcomes (4)
The time to peak (Tmax) of Rongliflozin.
To assess the effect of rifampicin and probenecid on the Tmax of rongliflozin
Measured: from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing
pharmacology (PD) of rongliflozin: cumulative urine glucose excretion every 24 hours
evaluate the cumulative urine glucose excretion every 24 hours after rongliflozin administration.
Measured: from 0 hour to 5 days after rongliflozin dosing
the number of participants with adverse events (AE) in Cohort A
To evaluate the safety and tolerability of single dose of rongliflozin and combination of rifampin
Measured: from screening to 3 days after last dose of rifampicin
the number of participants with adverse events (AE) in Cohort B
To evaluate the safety and tolerability of single dose of rongliflozin and combination of probenecid
Measured: from screening to 3 days after last dose of probenecid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start21 Feb 2022
- Primary completion22 Jul 2022
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497674
- Sponsor's protocol ID
- DJT1116PG-DM-108
- Status last verified
- Feb 2023
- First submitted
- 1 Aug 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study In Healthy Subjects To Assess The Effects Of Rifampicin Capsules and Probenecid Tablets On The Pharmacokinetic Profile Of Rongliflozin Capsules
- ClinicalTrials.gov ID
- NCT05497674
- Acronym / sponsor ID
- DJT1116PG-DM-108
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rongliflozin and/or rifampicin | Experimental | Drug: Rongliflozin, Drug: Rifampinon 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. |
| rongliflozin and/or probenecid | Experimental | Drug: Rongliflozin, Drug: Probenecidon 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rongliflozinoral administration, single dose on Day 1 and Day 11 | Drug | rongliflozin and/or rifampicin |
| RifampinQD for 10 days | Drug | rongliflozin and/or rifampicin |
| Rongliflozinoral administration, single dose on Day 1 and Day 6 | Drug | rongliflozin and/or probenecid |
| Probenecidtwice a day, for 5 days | Drug | rongliflozin and/or probenecid |
Primary outcome
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
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
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
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
4 secondary outcomes
The time to peak (Tmax) of Rongliflozin.
Time frame: from 0 hour（pre-dose,within 30mins）to 5 days after rongliflozin dosing
pharmacology (PD) of rongliflozin: cumulative urine glucose excretion every 24 hours
Time frame: from 0 hour to 5 days after rongliflozin dosing
the number of participants with adverse events (AE) in Cohort A
Time frame: from screening to 3 days after last dose of rifampicin
the number of participants with adverse events (AE) in Cohort B
Time frame: from screening to 3 days after last dose of probenecid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rongliflozin, Rifampin and Probenecid in people with Type 2 Diabetes Mellitus, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.