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

Phase 1

Not yet recruiting

• Conditions: Healthy Adult Subject; Overweight Subject
• Interventions: Drug: Repaglinide; Drug: Atorvastatin; Drug: Digoxin; Drug: Rosuvastatin; Drug: HDM1002

• Registration Number: NCT06601517
• Lead Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-14
• Last Update Submitted: 2024-09-14
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin	Repaglinide	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
HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin	Digoxin	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
HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin	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
HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin	HDM1002	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
HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin	Atorvastatin	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

Primary Outcome Measures

Name	Time	Method
AUC[0-∞]	Period 1 and Period 3: Day 1-Day 16	Pharmacokinetics (PK) parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 hour to ∞
AUC[0-t]	Period 1 and Period 3: Day 1-Day 16	PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 to t hour
Cmax	Period 1 and Period 3: Day 1-Day 16	PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Maximum observed concentration

Secondary Outcome Measures

Name	Time	Method
Tmax	Period 1 and Period 3: Day 1-Day 16	PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Time to maximum plasma concentration
t1/2	Period 1 and Period 3: Day 1-Day 16	PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Half life
CL/F	Period 1 and Period 3: Day 1-Day 16	PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent Clearance
Vz/F	Period 1 and Period 3: Day 1-Day 16	PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent volume of distribution
Adverse events (AEs)	Period 1 and Period 3: Day 1-Day 16, Period 2: Day 1-Day 35	Number of subjects reporting AEs

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China