A Phase I Study of LuoXin Innovate (LXI-15028) in Healthy Chinese Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability.

Healthy Clinical Trial

Official title: A Single-center, Randomized, Double-blinded and Placebo-controlled Clinical Study in Healthy Chinese Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability of LXI-15028 After Receiving Escalating Single Oral Doses of LXI-15028 at 50 mg, 100 mg and 200 mg and Multiple Oral Doses of LXI-15028 at 100 mg

Status Completed

Clinical Trial Summary

"This study is a single-center, randomized, double-blinded and placebo-controlled trial designed not only to assess pharmacokinetics, safety and tolerability of LXI-15028 but also to evaluate the pharmacokinetic characteristics of main metabolite M1 in vivo in 38 healthy adult Chinese subjects after receiving escalating single oral doses of 50 mg, 100 mg and 200 mg and multiple oral doses of 100 mg of LXI-15028.

Clinical Trial Description

This study includes 3 dose groups which are 50 mg (Group 1), 100 mg(Group 2) and 200 mg(Group 3) respectively. For 50 mg and 200 mg dose groups, each is planned to enroll 12 healthy subjects (investigational drug :placebo=10:2), half males and half females. Five subjects of each gender will receive LXI-15028, while 1 subject of each gender will receive placebo; 100 mg dose group plans to enroll 14 healthy subjects (investigational drug:placebo=10:4), half males and half females. Five subjects of each gender will receive LXI-15028, while 2 subjects of each gender will receive placebo. Intra-group randomization will be implemented in each dose group; each subject will receive either LXI-15028 or placebo.

This study includes 2 parts of single-dose and multiple-dose administration. The single-dose study will use gradually escalation dosing to evaluate the 3 doses of 50 mg, 100 mg and 200 mg. Within 4 days after each dose is administered, the investigators will assess the safety and tolerability data to decide whether to proceed with the next escalated single dose. Within 4 days of 200 mg single-dose administration, the investigators will assess the safety and tolerability data to decide whether to proceed with 100 mg multiple-dose study. Multiple-dose study will be investigated in 100 mg group only.

The study consists of screening period, treatment period and follow-up in each dose group. The treatment period in 50 mg and 200 mg dose groups include single-dose administration only. While the treatment period in 100 mg dose group includes both single-dose and multiple-dose administration. The subjects in 100 mg dose group will enter multiple-dose period following completing single-dose period.

In escalated single-dose study, the subjects in each dose group will receive single oral dose of 50 mg LXI-15028 tablet or 1 matching placebo tablet at fasted state, or 100 mg LXI-15028 tablet or matching placebo 1 tablet, or 2 100 mg LXI-15028 tablets or 2 matching placebo tablets. Blood samples will be collected before administration (0h), and 15 min (0.25h), 30 min (0.5h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after administration. In multiple-dose study, the subjects will continuously receive oral 100 mg LXI-15028 tablet or 1 matching placebo tablet once daily (QD) for 10 times. Blood samples of trough concentration will be collected before the 8th to 10th administration (0h) in multiple-dose study. And blood samples will be collected at 15 min (0.25h), 30 min (0.5h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after the 10th administration.

The collected blood samples will be processed to obtain plasma. Liquid Chromatographic(LC) /Mass Spectra(MS)/Mass Spectra (MS) method will be used to determine plasma concentrations of LXI-15028 and its major metabolite M1 in order to evaluate the pharmacokinetic characteristics of LXI-15028 and its metabolite M1 after oral administration of LXI-15028 tablet.

The safety will be assessed by physical examination, vital signs, ECG, laboratory examinations and adverse events in subjects receiving LXI-15028 tablet. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT03458650
• Study type: Interventional
• Source: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: March 19, 2018
• Completion date: May 8, 2018