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

NCT05109078 | Completed Phase 1

• 1 other identifier: DJT1116PG-DM-107
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Male Volunteers

Outcome Measures

Primary Outcomes (3)

• 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.

  up to 14 days

• Identification of the Proportion of different metabolites to determine biotransformation pathway of Rongliflozin

  Proportion of different metabolites(Rongliflozin and main metabolites).

  up to 14 days

• Distribution of radioactivity in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma

  Radioactivity concentration in whole blood and plasma samples.

  up to 11 days

Secondary Outcomes (2)

• 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

  up to 11 days

• Adverse events

  up to 21 days

Study Arms (1)

[14C]- Rongliflozin

EXPERIMENTAL

Patients will receive single dose of \[14C\]- Rongliflozin (Suspension, 50mg/100μCi)

Drug: [14C]- Rongliflozin

Interventions

[14C]- Rongliflozin DRUG

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

[14C]- Rongliflozin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Study Officials

• liyan Miao, MD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: December 9, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CN (1)