Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection
ConditionObesity or Overweight
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorGan & Lee Pharmaceuticals.
About this trial
This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of GZR18 Injection on gastric emptying and the effect of repeated SC injections of GZR18 Injection on the pharmacokinetics of oral digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets.
A total of 60 obese or overweight subjects are planned to be enrolled, with no less than one-quarter of the subjects from either gender.
The study duration for each subject in this study is approximately 26 weeks: including a screening period of up to 4 weeks (W-28 to D-1), single-drug administration and dose escalation stages of 16 weeks (W1D1 to W16D7) and the combined drug administration stage of 6 weeks (W17D1 to W23D1)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1.Obese Chinese subjects, who voluntarily sign the Informed Consent Form (ICF), can receive SC injection, fully understand the content, process and possible adverse reactions of the trial, and are able to follow the regulations on contraindications and restrictions specified in this protocol.
Disqualifiers
1.Subjects with a previous or existing history of heart, liver, kidney, gastrointestinal tract, respiratory system, nervous system, psychiatric disorders, endocrine diseases (except obesity), malignant tumors and other diseases that are judged by the investigator to have an impact on the evaluation of the results of this study.
Trial design
Design model
Single group
Treatments tested in this trial
GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets
DrugGZR18 injection: 3 mg-36 mg，16 weeks; Warfarin Sodium Tablets:2.5mg，twice; Rosuvastatin Calcium Tablets：10mg，twice; Digoxin Tablets:0.25mg，twice
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: GZR18 injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cmax:Maximum plasma concentration
Time frame
through study completion,up to 16 weeks2
AUC0-last:Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
Time frame
through study completion,up to 16 weeks3
AUC0-inf:Area under the plasma concentration-time curve at 0 h to infinity after a single dose.
Time frame
through study completion,up to 16 weeksSecondary outcomes
1
Tmax:Time of Maximum Drug Concentration
Time frame
through study completion,up to 16 weeks2
t1/2: Elimination half-life
Time frame
through study completion,up to 16 weeks3
CL/F: Apparent clearance rate
Time frame
through study completion,up to 16 weeks4
Vz/F:Apparent Volume of Distribution associated with the Terminal Phase following Oral Administration
Time frame
through study completion,up to 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov