Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSunshine Lake Pharma Co., Ltd.
About this trial
To evaluate the pharmacokinetics and safety of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
Eligibility criteria
Qualifiers
1. Sign the informed consent form before the trial；
2. subjects and must be 18 to 70 years of age inclusive, Male or female. body weight >50 kg (male) or ≥45 kg (female) at screening. (BMI) : 18-30 kg/m², (including critical value) [BMI= weight (kg)/height² (m²)] (BMI matching ±15% with liver dysfunction cohort);
3.Must be in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening；
4.Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
Disqualifiers
ALL subjects
1. The subject has been diagnosed with acquired immune deficiency syndrome (AIDS), or tests positive for human immunodeficiency virus (HIV).
2. Currently suffering from any bleeding disease, such as gastric and duodenal ulcer
3. Those who had undergone major surgery within 6 months before the screening period or the surgical incision did not completely heal;
Trial design
Treatments tested in this trial
- Larotinib
Treatment groups
32 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov