A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects.
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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: Repaglinide, Atorvastatin, Digoxin, Rosuvastatin.
- Who it may be relevant to
- Registry conditions: Healthy Adult Subject, Overweight 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, 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
Overview
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.
Interventions
- Drug Repaglinide
Single dose; Administered orally - Drug Atorvastatin
Single dose; Administered orally - Drug Digoxin
Single dose; Administered orally - Drug Rosuvastatin
Single dose; Administered orally - Drug HDM1002
Administered orally
Primary outcome measures
- AUC[0-∞] [Time frame: Period 1 and Period 3: Day 1-Day 16]
- AUC[0-t] [Time frame: Period 1 and Period 3: Day 1-Day 16]
- Cmax [Time frame: Period 1 and Period 3: Day 1-Day 16]
Secondary outcome measures (5)
- Tmax [Time frame: Period 1 and Period 3: Day 1-Day 16]
- t1/2 [Time frame: Period 1 and Period 3: Day 1-Day 16]
- CL/F [Time frame: Period 1 and Period 3: Day 1-Day 16]
- Vz/F [Time frame: Period 1 and Period 3: Day 1-Day 16]
- Adverse events (AEs) [Time frame: Period 1 and Period 3: Day 1-Day 16, Period 2: Day 1-Day 35]
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT06601517 · HDM1002-106