Health TrialsbyHealthPanel

Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function

ConditionsEsophageal CancerAdvanced Solid Tumor
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Larotinib

    Drug

    Capsules, Oral, 350 mg, single dose, one day

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Cohort A-LarotinibExperimental treatment 1 intervention
Group B: Cohort B-LarotinibExperimental treatment 1 intervention
Group C: Cohort C-LarotinibExperimental treatment 1 intervention
Group D: Cohort D-LarotinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cmax

Maximum plasma concentration of study drugs

Time frame
Day 1 to Day 7
2

Area Under Curve From 0 to Infinity (AUC0-infinity)

AUC0-infinity represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

Time frame
Day 1 to Day 7

Secondary outcomes

1

Adverse Event

New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Time frame
Day-7 to Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunshine Lake Pharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: