GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT06562088

Not yet recruitingPhase 1

A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects

A Phase I, Open-Label, Parallel, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of Rifampicin or Itraconazole on the Pharmacokinetics of HDM1002 in Healthy Adult Chinese Subjects

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Asset

HDM1002

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Healthy volunteers

Key I/E criterion

•BMI 19-32

Primary endpoints

•AUC[0-∞] of HDM1002•AUC[0-24 h] of HDM1002•Cmax of HDM1002

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06562088

Org study IDHDM1002-105

Timeline

Milestones

Study start2024-08-16estimated

Study first posted2024-08-20actual

Last update posted2024-08-20actual

Primary completion2024-11-19estimated

Study completion2024-12-30estimated

Assets

Investigational agents

HDM1002

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.

2. Age range of 18-45 years old (including range), no limit to gender.

3. Eligible male participant weighed ≥50.0 kg, eligible female participant weighed ≥45.0 kg, and had a body mass index (BMI) within the range of 19.0 - 32.0 kg/m2 (including cut-off values).

Exclusion criteria

1. Participant has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.

2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.

3. History of acute cholecystitis within 3 month prior to initiation of screening period.

4. Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.

5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.

6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .

7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.

8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.

9. Presence of clinically significant ECG results judged by the investigator at screening.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.