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NCT Number: NCT06601517

A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects.

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital

Beijing, China

Location contact

Cui Cheng

PRINCIPAL_INVESTIGATOR

Dongyang Liu

PRINCIPAL_INVESTIGATOR

Xiaohong Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).

Exclusion criteria

  • Subject 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 attack within 3 months prior to screening.
  • Subject 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.

Treatment and study plan

repaglinide

Drug

Single dose; Administered orally

atorvastatin

Drug

Single dose; Administered orally

Digoxin

Drug

Single dose; Administered orally

Rosuvastatin

Drug

Single dose; Administered orally

HDM1002

Drug

Administered orally

Primary outcomes

  1. AUC[0-∞]

    Time frame: Period 1 and Period 3: Day 1-Day 16

    Pharmacokinetics (PK) parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 hour to ∞

  2. AUC[0-t]

    Time frame: Period 1 and Period 3: Day 1-Day 16

    PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 to t hour

  3. Cmax

    Time frame: Period 1 and Period 3: Day 1-Day 16

    PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Maximum observed concentration

Secondary outcomes

  1. Tmax

    Time frame: Period 1 and Period 3: Day 1-Day 16

    PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Time to maximum plasma concentration

  2. t1/2

    Time frame: Period 1 and Period 3: Day 1-Day 16

    PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Half life

  3. CL/F

    Time frame: Period 1 and Period 3: Day 1-Day 16

    PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent Clearance

  4. Vz/F

    Time frame: Period 1 and Period 3: Day 1-Day 16

    PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent volume of distribution

  5. Adverse events (AEs)

    Time frame: Period 1 and Period 3: Day 1-Day 16, Period 2: Day 1-Day 35

    Number of subjects reporting AEs

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of HDM1002 on the Pharmacokinetics of Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy and Overweight Adult Chinese Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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