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

NCT ID: NCT06562088

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2024-12-30

Brief Summary

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.

Conditions

Healthy Adult Subject

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: HDM1002 and rifampicin

Part 1: Single dose of HDM1002

Part 2: Once daily dose of rifampicin with single dose of HDM1002

Group Type: EXPERIMENTAL

HDM1002 and rifampicin

Intervention Type: DRUG

Administered orally

Cohort 2: HDM1002 and itraconazole

Part 1: Single dose of HDM1002

Part 2: Once daily dose of itraconazole with single dose of HDM1002

Group Type: EXPERIMENTAL

HDM1002 and itraconazole

Intervention Type: DRUG

Administered orally

Interventions

HDM1002 and rifampicin

Administered orally

Intervention Type: DRUG

HDM1002 and itraconazole

Administered orally

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The second hospital of anhui medical university

Hefei, Anhui, China

Countries

China

Central Contacts

Wei hu

Role: CONTACT

hwgcp@ayefy.com

0551-65997164

Other Identifiers

HDM1002-105

Identifier Type: -

Identifier Source: org_study_id