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Healthy Adult Male VolunteersPhase 1NCT05109078

ADME Study of [14C]- Rongliflozin in Healthy Male Subjects

A Phase 1 study testing [14C]- Rongliflozin in people with Healthy Adult Male Volunteers, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]- Rongliflozin in healthy male subjects. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Adult Male Volunteers
What is being tested?
[14C]- Rongliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
9 Dec 2021to 31 Dec 2021
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males, 18 to 45 years at the time of screening.
  • Go to Weight>50 kg, Body mass index (BMI) is 19~26 kg/m2
  • Signing of informed consent
  • Participants are able to communicate well with the investigators and be able to complete the trial according to the Process.

Who cannot join

  • Physical examination, routine laboratory tests, 12-lead ECG, Chest X-ray, abdominal B-ultrasound, New Coronavirus Testing and other is abnormal and clinically significant.
  • Positive testing for HIV, HBsAg, HBeAb, HCVAb or Syphilis antibody.
  • CYP3A4, uridine diphosphoglucuronyl transferase(UGT) inducers or inhibitors, and P-gp, breast cancer resistance protein(BCRP) Substrates were taken within 28 days before screening.
  • Use of any prescription or over-the-counter drug, any vitamin product, health care drug or Chinese herbal medicine within 14 days prior to screening.
  • Participants who have participated in any clinical trials within 3 months prior to screening and have used thetest drug or medical devices.
  • Participants who have been vaccinated within 1 month before screening or plan to be vaccinated during the trial period.
Show all 24Show fewer
  • A history of any clinically serious illness or condition, including but not limited to circulatory, endocrine, nervous,digestive, urinary, or blood, immune, mental, and metabolic diseases, that the investigator considers to be likely to affect the results of the study.
  • People who have had heart disease such as heart failure, angina pectoris, myocardial infarction, and clinically significant arrhythmia.
  • A history of urinary tract infection or repeated hypoglycemia.
  • Participants who had undergone major surgery or whose surgical incision was not completely healed within 6 months before the screening period;Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury.
  • Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred withini 6 months before screening.
  • Significant clinical bleeding symptoms or definite bleeding tendency occurred within 3 months before screening.
  • Hemorrhoids or perianal diseases with regular/bleeding in the stool; Patients with gastrointestinal dysfunction, such as irritable bowel syndrome and inflammatory bowel disease, may be affected by drug absorption as determined by researchers.
  • Participants who have allergies or have special dietary requirements and cannot follow the standard diet.
  • Habitual constipation or diarrhea.
  • Heavy drinking or regular drinking in the six months preceding the screening period, or alcohol breath test results ≥20 mg/dL during the screening period.
  • Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period.
  • Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, phenylcyclohexidine, etc.) in the 1 year prior to the screening period, or screening for positive urine drug abuse (drug) tests.
  • Habitual consumption of grapefruit juice or excessive consumption of tea, coffee and/or caffeinated beverages and failure to abstain during the study period.
  • Those with a history of fainting needle or blood, have difficulty in blood collection or cannot tolerate vein puncture for blood collection.
  • Workers engaged in conditions requiring long-term exposure to radioactivity; or have significant radiation exposure (≥2 chest/abdomen CT, or ≥3 other types of X-ray examinations) within 1 year before the test or have participated inthe radiopharmaceutical labeling test.
  • Having family planning during the trial period and within 12 months after the last use of the drug, or not agreeing that subjects and their spouses should take strict contraceptive measures during the trial period and within 12 months after the last use of the drug.
  • Those who have lost blood or donated up to 400 mL within 3 months before the screening period, or those who have received blood transfusion, or those who plan to donate blood within 3 month after the end of this test.
  • As determined by the investigator, the subject has other factors that are not suitable for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]- Rongliflozin in Healthy Male Participants

Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]- Rongliflozin in healthy male subjects.

Being tested
[14C]- Rongliflozin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]- RongliflozinDrug

    Patients will receive single dose of orally [14C]- Rongliflozin on Day 1

Study groups in NCT05109078
Study groupRoleWhat they receive
[14C]- RongliflozinExperimentalPatients will receive single dose of [14C]- Rongliflozin (Suspension, 50mg/100μCi)
Receives: Drug: [14C]- Rongliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative excretion of 14C-labeled drug-related material (radioactivity in urine and fecal samples)

    Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine and feces.

    Measured: up to 14 days

  2. Identification of the Proportion of different metabolites to determine biotransformation pathway of Rongliflozin

    Proportion of different metabolites(Rongliflozin and main metabolites).

    Measured: up to 14 days

  3. Distribution of radioactivity in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma

    Radioactivity concentration in whole blood and plasma samples.

    Measured: up to 11 days

Secondary outcomes (2)

  1. Quantitive analysis of the concentrations of Rongliflozinand main metabolites in plasma using the validated liquid chromatography-tandem mass spectrometry(LC-MS/MS) to obtain pharmacokinetic data

    The concentrations of Rongliflozin and main metabolites in plasma.

    Measured: up to 11 days

  2. Adverse events

    Adverse events assessed by CTCAE v5.0.

    Measured: up to 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2021
  2. Study start9 Dec 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05109078
Sponsor's protocol ID
DJT1116PG-DM-107
Status last verified
Apr 2023
First submitted
26 Oct 2021
Last updated
12 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]- Rongliflozin in people with Healthy Adult Male Volunteers, 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 4 inclusion and 24 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 12 Apr 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?

Cumulative excretion of 14C-labeled drug-related material (radioactivity in urine and fecal samples) (time frame: up to 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05109078.

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 12 Apr 2023.

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