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

NCT06601517 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HDM1002-106
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Subject; Overweight Subject

Keywords

HDM1002; Glucagon-Like Peptide-1 Receptor Agonists

Outcome Measures

Primary Outcomes (3)

• AUC[0-∞]

  Pharmacokinetics (PK) parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 hour to ∞

  Period 1 and Period 3: Day 1-Day 16

• AUC[0-t]

  PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 to t hour

  Period 1 and Period 3: Day 1-Day 16

• Cmax

  PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Maximum observed concentration

  Period 1 and Period 3: Day 1-Day 16

Secondary Outcomes (5)

• Tmax

  Period 1 and Period 3: Day 1-Day 16

• t1/2

  Period 1 and Period 3: Day 1-Day 16

• CL/F

  Period 1 and Period 3: Day 1-Day 16

• Vz/F

  Period 1 and Period 3: Day 1-Day 16

• Adverse events (AEs)

  Period 1 and Period 3: Day 1-Day 16, Period 2: Day 1-Day 35

Study Arms (1)

HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin

EXPERIMENTAL

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

Drug: Repaglinide; Drug: Atorvastatin; Drug: Digoxin; Drug: Rosuvastatin; Drug: HDM1002

Interventions

Repaglinide DRUG

Single dose; Administered orally

HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin

Atorvastatin DRUG

Single dose; Administered orally

HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin

Digoxin DRUG

Single dose; Administered orally

HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin

Rosuvastatin DRUG

Single dose; Administered orally

HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin

HDM1002 DRUG

Administered orally

HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
• History of acute cholecystitis attack within 3 months prior to screening.
• 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.
• History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
• During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
• Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
• History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
• Presence of clinically significant ECG results judged by the investigator at screening.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Interventions

repaglinide; Atorvastatin; Digoxin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Central Study Contacts

Cheng Cui

CONTACT

+86-010 82266455; cuicheng1226@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

CN (1)