Study site 01
Beijing, China
NCT Number: NCT07119450
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).
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will get a single dose of [14C]GZR18 injection
Time frame: Through study completion, an average of 1 year
The total radioactivity recovery at each interval and the cumulative total radioactivity recovery in excreta (urine and feces).
Time frame: Through study completion, an average of 1 year
Percentage of parent drug and its metabolites (if applicable) in plasma in total radioactivity exposure in plasma; percentage of parent drug and its metabolites (if applicable) in urine and feces in administered dose; identification of major metabolites in plasma, urine, and feces.
Time frame: Through study completion, an average of 1 year
Peak Plasma Concentration (Cmax)
Time frame: Through study completion, an average of 1 year
Area under the plasma concentration versus time curve (AUC)
Time frame: Through study completion, an average of 1 year
Ratio of total radioactivity concentration in whole blood to plasma
Time frame: Through study completion, an average of 1 year
Time-To-Peak(Tmax)
Time frame: Through study completion, an average of 1 year
Mean Residence Time
Time frame: Through study completion, an average of 1 year
Half-Life Period(T1/2)
Time frame: Through study completion, an average of 1 year
Peak Plasma Concentration (Cmax)
Time frame: Average of 1 year
weight and height will be combined to report BMI in kg/m^2
Time frame: Through study completion, an average of 1 year
Area under the plasma concentration versus time curve (AUC)
Time frame: through study completion, an average of 1 year
Time-To-Peak(Tmax)
Time frame: through study completion, an average of 1 year
Mean Residence Time
Time frame: through study completion, an average of 1 year
Half-Life Period(T1/2)
Time frame: Average of 1 year
laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, stool analysis + occult blood and thyroid function)
Gan & Lee Pharmaceuticals.
Industry
A Mass Balance Study of [14C] GZR18 in Chinese Overweight or Obese Male Subjects
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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