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Status unknownNCT06562088Updated Aug 20, 2024

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

A Phase 1 interventional study of HDM1002 and rifampicin and HDM1002 and itraconazole in Healthy Adult Subject, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (part of Huadong Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Adult Subject

Keywords

  • HDM1002 tablet
  • Glucagon-Like Peptide-1 Receptor Agonists
03

In context

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. is the lead sponsor of 50 studies on the registry; 38 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. studies →All Huadong Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugHDM1002 and rifampicin

    Administered orally

  • DrugHDM1002 and itraconazole

    Administered orally

06

What researchers measure

Primary outcomes

  1. AUC[0-∞] of HDM1002

    Pharmacokinetics (PK) parameter : Area under the curve from time 0 hour to ∞

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

  2. AUC[0-24 h] of HDM1002

    PK parameter : Area under the curve from time 0 to 24 hour

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

  3. Cmax of HDM1002

    PK parameter : Maximum observed concentration

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

  4. AUC[0-t] of HDM1002

    PK parameters : Area under the curve from time 0 to t hour

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

  5. Tmax of HDM1002

    PK parameters : Time to maximum plasma concentration

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

  6. t1/2 of HDM1002

    PK parameters : Half life

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

  7. CL/F of HDM1002

    PK parameters : Apparent Clearance

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

  8. Vz/F of HDM1002

    PK parameters : Apparent volume of distribution

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

Secondary outcomes

  1. AUC[0-∞] of HDM1002 metabolites

    PK parameters : Area under the curve from time 0 hour to ∞

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

  2. AUC[0-24 h] of HDM1002 metabolites

    PK parameters : Area under the curve from time 0 to 24 hour

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

  3. Cmax of HDM1002 metabolites

    PK parameters : Maximum observed concentration

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

  4. AUC[0-t] of HDM1002 metabolites

    PK parameters : Area under the curve from time 0 to t hour

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

  5. Tmax of HDM1002 metabolites

    PK parameters : Time to maximum plasma concentration

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

  6. t1/2 of HDM1002 metabolites

    PK parameters: Half life

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

  7. CL/F of HDM1002 metabolites

    PK parameters : Apparent Clearance

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

  8. Vz/F of HDM1002 metabolites

    PK parameters : Apparent volume of distribution

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

  9. Adverse events (AEs)

    Number of subjects reporting AEs

    Time frame: Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13

07

Study locations

1 site
  • The second hospital of anhui medical university
    Hefei, Anhui, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06562088
Lead sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Aug 20, 2024
Start date
Aug 16, 2024 (estimated)
Primary completion
Nov 19, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Aug 20, 2024

Study contacts

Wei hu
Contact
hwgcp@ayefy.com
0551-65997164

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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