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NCT07119450CompletedPhase 1

The Study of [14C] GZR18

A Mass Balance Study of [14C] GZR18 in Chinese Overweight or Obese Male Subjects

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

This trial is a Single-center, non-randomized, open-label, single-dose Mass Balance Study. The study period of each subject consists of a screening period (D-21 to D-2), a baseline period (D-2 to D-1), a dosing and routine collection period (D1 to D36) and an intermittent collection and follow-up period (D36 to D78, during which subjects should visit the hospital once a week, 6 visits in total).

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
6 (actual)
First submitted
9 Jul 2025
Start date
7 May 2025
Primary completion date
13 Aug 2025
Lead sponsor
Gan & Lee Pharmaceuticals.
Diseases
Obesity
NCT number
NCT07119450

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 6
  • From 7 May 2025 to the primary completion date, 13 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects who suffer from dyspepsia, esophageal reflux, peptic ulcer or gallbladder disease within 3 months prior to dosing, or any gastrointestinal disease that may affect gastric emptying, or any surgical procedure (such as cholecystectomy, except for appendicitis surgery) that may affect drug metabolism or excretion; or plan to undergo surgery during the study.
  • Subjects who used any prescription drugs, OTC drugs, Chinese herbal medicines, food supplements (including vitamins, health food, etc.) within 14 days before dosing, or have other non-drug therapeutic factors affecting drug absorption, distribution, metabolism and excretion.
  • ubjects who have received any other investigational drug or participated in any other interventional clinical study within 3 months prior to screening, or still within 5 half-lives of a previously administered investigational drug at screening, whichever is longer.
  • Subjects who smoked \> 5 cigarettes/day on average (or used an equivalent amount of nicotine products) in 6 months prior to screening, or are unwilling to abstain from tobacco products during the study.

Other illness

  • Subjects with other clinically significant diseases or medical history that may hinder the subject from following the study protocol and completing this study as judged by the investigator.

Lab values

  • Subjects with abnormalities in vital signs, physical examination, routine laboratory tests (hematology, urinalysis, stool analysis + occult blood, blood chemistry and coagulation function), chest X-ray (AP view) or abdominal B-scan ultrasonography at screening or baseline, which are deemed clinically significant by the investigator; subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin exceeding the normal range at screening/baseline, which are deemed clinically significant by the investigator.

Other

  • Difficulty in blood collection or intolerance to venipuncture for blood collection.
  • Those who are not eligible for the study for other reasons as judged by the investigator.

Who the study is looking for

  • Subjects must be fully informed, know and understand the content, process and possible treatment-related adverse events (TRAEs) before the study, and voluntarily sign a written informed consent form;
  • Chinese adult male subjects aged 18-55 (inclusive);
  • Body weight ≥ 50 kg;
  • Subjects with stable physical activity and lifestyle and relatively stable weight within 3 months prior to screening (as per inquiry);
  • Subjects have no sperm donation plan within 6 months after the last dose, and subjects and their partners have no pregnancy plan throughout the study and within 6 months after the last dose and voluntarily take effective contraceptive measures to avoid pregnancy of their partners.

Age in the registry: 18 years to 55 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.