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

NCT06562088 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HDM1002-105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

HDM1002 tablet; Glucagon-Like Peptide-1 Receptor Agonists

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (9)

• AUC[0-∞] of HDM1002 metabolites

  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

  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

  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

  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

  Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13

Study Arms (2)

Cohort 1: HDM1002 and rifampicin

EXPERIMENTAL

Part 1: Single dose of HDM1002 Part 2: Once daily dose of rifampicin with single dose of HDM1002

Drug: HDM1002 and rifampicin

Cohort 2: HDM1002 and itraconazole

EXPERIMENTAL

Part 1: Single dose of HDM1002 Part 2: Once daily dose of itraconazole with single dose of HDM1002

Drug: HDM1002 and itraconazole

Interventions

HDM1002 and rifampicin DRUG

Administered orally

Cohort 1: HDM1002 and rifampicin

HDM1002 and itraconazole DRUG

Administered orally

Cohort 2: HDM1002 and itraconazole

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.
• 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).

You may not qualify if:

• 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.
• History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
• History of acute cholecystitis within 3 month prior to initiation of screening period.
• 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.
• 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)

The second hospital of anhui medical university

Hefei, Anhui, China

Location

MeSH Terms

Interventions

Rifampin; Itraconazole

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines

Central Study Contacts

Wei hu

CONTACT

0551-65997164; hwgcp@ayefy.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 20, 2024
• Study Start: August 16, 2024
• Primary Completion: November 19, 2024
• Study Completion: December 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

CN (1)