NCT03655873

The Study of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH,in Healthy Subjects

Safety, Tolerability, and Pharmacokinetics Phase ⅠStudy of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH, Following Single and Multiple Ascending Doses，Single-center, Randomized, Double-blind in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of a selective 5-ht6 receptor antagonist, HEC30654AcOH,in healthy subjects.This test is divided into two parts, the first part is the healthy adult subjects single ascending-dose research;The second part is the healthy adult subjects multiple ascending-dose research.

Detailed description

The single ascending-dose research: There have set up seven dose group(5、10、15、30、60、90、120mg）.The first group(5mg)contains 3 health subjects，Which have been a preliminary experimental group. Each other groups contains 10 health subjects(8 health subjects take experimental drugs,2 health subjects take the placebo).Within 15min before taking the medicine and after 0.5h, 1h, 1.5h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 120h to take blood samples for pharmacokinetics(PK) detection. The multiple ascending-dose research: There have set up three dose group(15、30、60mg）.Each group contains 12 health subjects(10 health subjects take experimental drugs,2 health subjects take the placebo).Each dose group in D1-D7 8:00（±1h）in the morning, 18:00（±1h）, with 240 ml warm water to take corresponding study drug，but Day 8 only 8:00（±1h） in the morning take subjects drugs.Total for 15 times.on the morning of day 1 within 15minutes before the first drug and after 0.5h, 1h, 1.5h, 2h, 4h, 6h, 8h, 10h, 12h, on the morning of Day 6, Day 7 and Day 8 within 15 minutes before the drug collecting blood sample test concentration, on the morning of Day8 medication after 0.5h 1h, 1.5h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 120h collects pharmacokinetics(PK) blood samples.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HEC30654AcOH capsule	single ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg HEC30654AcOH capsule in day1. Multiple ascending-dose study: 15-、30-、60mgHEC30654AcOH capsule in day1-day7，2 times everyday.
DRUG	Placebo capsule	single ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg placebo capsule in day1. Multiple ascending-dose study: 15-、30-、60mg placebo capsule in day1-day7，2 times everyday.

Timeline

• Start date: 2018-11-21
• Primary completion: 2019-10-30
• Completion: 2019-11-30
• First posted: 2018-08-31
• Last updated: 2019-04-04

Locations

1 site across 1 country: China