A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of HS-10506
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Moderate Hepatic Impairment Study Phase This phase employs a multicenter, open-label, parallel-group, single-dose study design.Two cohorts are established in this phase: Cohort A: Subjects with moderate hepatic impairment Cohort B: Subjects with normal hepatic function A total of 8 subjects of either gender will be enrolled in each cohort. Enrolled subjects will be admitted to the Phase I clinical research unit on Day -1 and fasted for at least 10 hours. On Day 1, subjects will receive a single oral dose of 20 mg HS-10506 tablets in a fasted state. Water intake is prohibited within 1 hour before and after dosing (excluding water used for drug administration). Food intake is restricted for at least 4 hours post-dose. All study medications will be administered with approximately 240 mL of water. Subjects with normal hepatic function (Cohort B) serve as the matched control group for subjects with moderate hepatic impairment (Cohort A), and shall meet the following matching criteria: The mean body mass index (BMI) of Cohort B is within ±10% of the mean BMI of Cohort A. The mean age of Cohort B is within ±3 years of the mean age of Cohort A. The number of male and female subjects in Cohort B is consistent with that in Cohort A for each gender. Mild Hepatic Impairment Study Phase Based on the results of the moderate hepatic impairment study phase, the sponsor and principal investigator will jointly determine whether to conduct a study to evaluate the effect of mild hepatic impairment. The phase design and procedures of the mild hepatic impairment are consistent with those of the moderate hepatic impairment. Subjects with normal hepatic function (Cohort D) serve as the matched control group for subjects with mild hepatic impairment (Cohort C), and shall meet the following matching criteria: The mean BMI of Cohort D is within ±10% of the mean BMI of Cohort C. The mean age of Cohort D is within ±3 years of the mean age of Cohort C. The number of male and female subjects in Cohort D is consistent with that in Cohort C for each gender.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Osoby mające ukończone 18 lat.
- •Osoby rozumiejące cel badania i zgadzające się na udział.
- •Osoby z łagodnymi lub umiarkowanymi, stabilnymi problemami z wątrobą od co najmniej 2 miesięcy.
- •Osoby zdrowe, podobne do pacjentów pod względem wieku, wagi i budowy ciała.
✗ Disqualifies
- •Osoby z bardzo wysokim poziomem pewnej substancji we krwi (AFP powyżej 20 ng/mL).
- •Osoby z problemami psychicznymi, skłonnościami do samookaleczania lub prób samobójczych.
- •Osoby z innymi poważnymi chorobami (układu nerwowego, pokarmowego, krążenia, oddechowego itp.).
- •Osoby z aktywnymi chorobami żołądka lub przełyku (np. zgaga, refluks).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 28, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
No. 121, Wanshui Road, Hefei High-tech Zone
Hefei, China
Trial contact
Huan Zhou, Doctorate
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/29/2026.
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