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Not yet recruiting NCT07502001

Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin

Phase I Interventional Overweight Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acetaminophen, Metformin, Warfarin, Atorvastatin.
Who it may be relevant to
Registry conditions: Overweight, Obesity. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Influence of HDM1005 on Gastric Emptying and Drug-Drug Interaction of HDM1005 and Metformin, Atorvastatin, Warfarin, and Digoxin in Overweight/Obese Adult Chinese Subjects

Overview

The purpose of this study is to characterize the Influence of HDM1005 on gastric emptying and drug-drug interaction of HDM1005 and metformin, atorvastatin, warfarin, and digoxin in overweight/obese adult subjects.

Interventions

  • Drug Acetaminophen
    Single dose; Administered orally
  • Drug Metformin
    Single dose; Administered orally
  • Drug Warfarin
    Single dose; Administered orally
  • Drug Atorvastatin
    Single dose; Administered orally
  • Drug Digoxin
    Single dose; Administered orally
  • Drug HDM1005 injection
    Subcutaneous injection QW

Primary outcome measures

  • Area Under the Concentration Time Curve From Time Zero to ∞ [ AUC(0- ∞)] [Time frame: Up to Day 115]
  • Maximum observed concentration (Cmax) [Time frame: Up to Day 115]
  • Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] [Time frame: Up to Day 115]
  • Time of maximum observed concentration (Tmax) [Time frame: Up to Day 115]
Secondary outcome measures (5)
  • Adverse events (AEs) [Time frame: Up to Day 115]
  • Apparent volume of distribution (Vz/F) [Time frame: Up to Day 115]
  • Time of maximum observed concentration (Tmax) [Time frame: Up to Day 115]
  • Maximum observed concentration (Cmax) [Time frame: Up to Day 115]
  • Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] [Time frame: Up to Day 115]

Eligibility criteria

Inclusion criteria

  • Aged between 18 and 45 years (inclusive), regardless of gender.
  • Male participants with body weight ≥50.0 kg, female participants with body weight ≥45.0 kg, and body mass index (BMI = weight \[kg\]/height² \[m²\]) within the range of 24.0 to 35.0 kg/m² (inclusive).
  • In the opinion of the investigator, participants are in generally good health based on medical history, clinical laboratory tests, vital signs, 12-lead ECG results, and physical examination findings at screening.
  • Provide signed informed consent form (ICF) prior to the trial, and have a thorough understanding of the trial content, procedures, and possible adverse reactions. Participants must be able to communicate well with the investigator, and understand and comply with the requirements of this study.

Exclusion criteria

  • Participants with a medical history or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
  • History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
  • History of an acute episode of cholecystitis within 3 months prior to screening.
  • Experienced severe hypoglycemic events or recurrent hypoglycemic events (≥3 hypoglycemic events per week, or other hypoglycemic events as judged by the investigator) within 3 months prior to screening.
  • Blood donation, significant blood loss (≥400 mL), or use of blood products within 3 months prior to screening or between screening and the first dose.
  • Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications, whichever is longer (excluding contraceptives).
  • Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer).
  • Female participants who are breastfeeding or pregnant.
  • Participants with any other factors that, in the opinion of the investigator, make them unsuitable for participation in this trial (e.g., medical, psychological, or psychiatric conditions, social or geographical factors)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Anhui Medical University — Hefei

Identifiers

NCT: NCT07502001 · HDM1005-104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗