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Not yet recruiting NCT06562088

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

Phase I Interventional Healthy Adult Subject

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HDM1002 and rifampicin, HDM1002 and itraconazole.
Who it may be relevant to
Registry conditions: Healthy Adult Subject. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug HDM1002 and rifampicin
    Administered orally
  • Drug HDM1002 and itraconazole
    Administered orally

Primary outcome measures

  • AUC[0-∞] of HDM1002 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [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 outcome measures (9)
  • AUC[0-∞] of HDM1002 metabolites [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The second hospital of anhui medical university — Hefei

Identifiers

NCT: NCT06562088 · HDM1002-105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗