A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-04-30

Brief Summary

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The purpose of this study is to characterize the effect of HDM1002 on the PK of single dose of repaglinide, atorvastatin, digoxin and rosuvastatin in healthy adult subjects. The safety and tolerability of HDM1002 with repaglinide, atorvastatin, digoxin and rosuvastatin when given separately or together will also be evaluated.

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Detailed Description

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Conditions

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Healthy Adult Subject Overweight Subject

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin

Period 1: Single dose of repaglinide, atorvastatin, digoxin and rosuvastatin

Period 2: Once daily dose of HDM1002

Period 3: Single dose of repaglinide, atorvastatin, digoxin and rosuvastatin with once daily dose of HDM1002

Group Type EXPERIMENTAL

Repaglinide

Intervention Type DRUG

Single dose; Administered orally

Atorvastatin

Intervention Type DRUG

Single dose; Administered orally

Digoxin

Intervention Type DRUG

Single dose; Administered orally

Rosuvastatin

Intervention Type DRUG

Single dose; Administered orally

HDM1002

Intervention Type DRUG

Administered orally

Interventions

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Repaglinide

Single dose; Administered orally

Intervention Type DRUG

Atorvastatin

Single dose; Administered orally

Intervention Type DRUG

Digoxin

Single dose; Administered orally

Intervention Type DRUG

Rosuvastatin

Single dose; Administered orally

Intervention Type DRUG

HDM1002

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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. Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).

Exclusion Criteria

1. Subject 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 attack within 3 months prior to screening.
4. Subject 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes