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

NCT03655873 | Completed Phase 1

• 1 other identifier: HEC30654-P-01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Adverse events of the single ascending-dose

  To assess the safe and tolerability of the single ascending-dose

  From the baseline to 6 days

• Adverse events of the multiple ascending-dose

  To assess the safe and tolerability of the multiple ascending-dose

  From the baseline to 13 days

Secondary Outcomes (6)

• Maximum Plasma Concentration(Cmax)

  Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing

• Area Under the Curve(AUC)

  Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing

• Maximum Peak Time(Tmax)

  Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing

• Mean Residence Time(MRT)

  Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing

• Terminal elimination half-life(T1/2)

  Prior to dosing（0h）and 0.5h,1h,1.5h,2h,4h,6h,8h,10h,12h,24h,48h,72h,96h,120h after dosing

Study Arms (2)

HEC30654AcOH capsule

EXPERIMENTAL

single ascending-dose study: Including 7 dose groups(5-、10、15-、30-、60-、90-、120mg)，Day1 ante meridiem(AM) 8:00 (±1h) with 240ml warm water to taking the experiment drug，On an empty stomach . multiple ascending-dose study: Including 3 dose groups(15-、30-、60mg),Day1-Day7 AM 8:00 (±1h), 18:00 Post Meridiem(PM) (±1h), with 240ml warm water to take the experiment drug On an empty stomach;Day8 AM 8:00 (±1h)with 240ml warm water to taking the experiment drug，On an empty stomach.

Drug: HEC30654AcOH capsule

placebo capsule

PLACEBO COMPARATOR

single ascending-dose study: Including 6 dose groups(10、15-、30-、60-、90-、120mg)，Day1 morning 8:00 (±1h) with 240ml warm water to taking the placebo capsule，On an empty stomach . multiple ascending-dose study: Including 3 dose groups(15-、30-、60mg),Day1-Day7 AM 8:00 (±1h), 18:00 PM (±1h), with 240ml warm water to take the placebo capsule on an empty stomach;Day8 AM 8:00 (±1h)with 240ml warm water to taking the placebo capsule，on an empty stomach.

Drug: Placebo capsule

Interventions

HEC30654AcOH capsule DRUG

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.

HEC30654AcOH capsule

Placebo capsule DRUG

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.

placebo capsule

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• signing informed consent, and fully understanding the study's content, process，possible adverse reaction before the study beginning.
• Be able to complete the study in accordance with the requirements of the study.
• Subjects (including partner) which from screening to the last time of study drug dosage volunteered to take effective contraceptive measures within 6 months, see appendix for birth control measures.
• Age of 18 to 45 years old male and female subjects (including 18 and 45 years of age).
• Male subjects not less than 50 kg, female subjects not less than 45 kg weight.Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index (BMI) within the scope of 18 \~ 28 kg/m2 (including threshold).
• Physical examination, vital signs is normal or abnormal has no clinical significance.

You may not qualify if:

• months before the study daily smoking more than 5 pieces.
• having allergies or allergic constitution for experiment drugs (a variety of drugs and food allergies).
• Has a history of drug and/or binge drinking (drinking 14 units of alcohol every week: 1 unit = 285 mL beer, or liquor 25 mL, or wine 100 mL).
• Three months before screening blood or blood loss (\> 450 mL).
• days before the screening taking any drugs of changing liver enzymes.
• Within 14 days before the screening taken any prescription drugs, over-the-counter drugs, vitamins or herbal products.
• Within 2 weeks before the screening taking any special diet (including dragon fruit, mango, pomelo, etc.) or with vigorous exercise, or other affect drug absorption, distribution, metabolism and excretion.
• With the following CYP3A4, P - gp or Bcrp inhibitors or inducers, such as itraconazole, ketone health zun or definitely nida, lung, etc.
• Recently, very large changes in diet or exercise habits.
• Three months before taking study drug, there taken study drug and its analogues, or participated in drug clinical trials.
• Having difficulty swallowing or any digestive system diseases history affecting drug absorption, excretion,etc.
• Having had any increased risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc.
• Abnormal ecg that have clinical significance.
• Female subjects in screening test is in lactation or have positive serum pregnancy outcomes.
• Clinical laboratory examination were abnormal clinical significance, or other clinical findings show that there are clinical significance of the following diseases (including but not limited to the gastrointestinal tract, liver, kidney, and nerve, blood, endocrine, tumor, lung, immune, spirit, or disease of heart head blood-vessel).

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 31, 2018
• Study Start: November 21, 2018
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: May 1, 2026

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)