A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
About this trial
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age and Sex: Chinese subjects aged 18-70 years (inclusive) at screening, regardless of gender. The normal hepatic function group and hepatic impairment group must be age-matched within ±10 years, with gender matching as close as possible (±1 subject per gender).
Body Weight and Body Mass Index (BMI): At screening, male subjects must weigh ≥50.0 kg, and female subjects ≥40.0 kg, with a BMI ranging from 19.0 to 32.0 kg/m² (inclusive).The normal hepatic function group and hepatic impairment group must be weight-matched within ±10 kg.
Disqualifiers
History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2; or serum calcitonin ≥50 ng/L at screening.
History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to signing the informed consent form (ICF).
History of acute gallbladder disease within 3 months prior to signing the ICF.
History of Malignancy: Diagnosis of any malignancy within 5 years prior to ICF signing (except basal cell carcinoma treated with curative intent and deemed cured).
Trial design
Design model
Parallel
Treatments tested in this trial
Single dose of HDM1002 on Day 1
DrugSingle dose of HDM1002 will be administered on Day 1
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Subjects Without Hepatic ImpairmentExperimental treatment 1 intervention
Group B: Subjects With Mild Hepatic ImpairmentExperimental treatment 1 intervention
Group C: Subjects With Moderate Hepatic ImpairmentExperimental treatment 1 intervention
Group D: Subjects With Severe Hepatic ImpairmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Plasma Concentration (Cmax)
Maximum observed plasma of HDM1002 concentration.
Time frame
Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.2
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
Area under the plasma HDM1002 concentration-time profile from time 0 extrapolated to infinite time.
Time frame
Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.3
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t)
Area under the plasma HDM1002 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.
Time frame
Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.4
Fraction of Unbound Drug in Plasma (fu)
fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).
Time frame
Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.Sponsors and contacts
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Source ClinicalTrials.gov