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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Subject
• Intervention / Treatment: Drug: HDM1002 and rifampicin; Drug: HDM1002 and itraconazole

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei hu; Phone Number: 0551-65997164; Email: hwgcp@ayefy.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: HDM1002 and rifampicin; Part 1: Single dose of HDM1002 Part 2: Once daily dose of rifampicin with single dose of HDM1002	Drug: HDM1002 and rifampicin; Administered orally
Experimental: Cohort 2: HDM1002 and itraconazole; Part 1: Single dose of HDM1002 Part 2: Once daily dose of itraconazole with single dose of HDM1002	Drug: HDM1002 and itraconazole; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC[0-∞] of HDM1002	Pharmacokinetics (PK) parameter : Area under the curve from time 0 hour to ∞	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-24 h] of HDM1002	PK parameter : Area under the curve from time 0 to 24 hour	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Cmax of HDM1002	PK parameter : Maximum observed concentration	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-t] of HDM1002	PK parameters : Area under the curve from time 0 to t hour	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Tmax of HDM1002	PK parameters : Time to maximum plasma concentration	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
t1/2 of HDM1002	PK parameters : Half life	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
CL/F of HDM1002	PK parameters : Apparent Clearance	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Vz/F of HDM1002	PK parameters : Apparent volume of distribution	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC[0-∞] of HDM1002 metabolites	PK parameters : Area under the curve from time 0 hour to ∞	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-24 h] of HDM1002 metabolites	PK parameters : Area under the curve from time 0 to 24 hour	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Cmax of HDM1002 metabolites	PK parameters : Maximum observed concentration	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
AUC[0-t] of HDM1002 metabolites	PK parameters : Area under the curve from time 0 to t hour	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Tmax of HDM1002 metabolites	PK parameters : Time to maximum plasma concentration	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
t1/2 of HDM1002 metabolites	PK parameters: Half life	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
CL/F of HDM1002 metabolites	PK parameters : Apparent Clearance	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Vz/F of HDM1002 metabolites	PK parameters : Apparent volume of distribution	Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
Adverse events (AEs)	Number of subjects reporting AEs	Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 16, 2024
• Primary Completion (Estimated): November 19, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Glucagon-Like Peptide-1 Receptor Agonists; HDM1002 tablet
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Leprostatic Agents; Hormone Antagonists; Cytochrome P-450 Enzyme Inducers; Antifungal Agents; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; 14-alpha Demethylase Inhibitors; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin; Itraconazole
• Other Study ID Numbers: HDM1002-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No