A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03005

Luye Pharma Group Ltd.1 site in 1 country88 target enrollmentFebruary 2014

ConditionsMajor Depressive Disorder

InterventionsLY03005 Placebo Meal Pristiq

DrugsLY03005 Placebo Pristiq

Overview

Phase: Phase 1
Intervention: LY03005
Conditions: Major Depressive Disorder
Sponsor: Luye Pharma Group Ltd.
Enrollment: 88
Locations: 1
Primary Endpoint: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of escalating single oral doses of LY03005 in healthy subjects and to characterize the pharmacokinetics (PK) of escalating single oral doses of LY03005.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Luye Pharma Group Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Are capable of giving informed consent and complying with study procedures;
•Are between the ages of 18 and 45 years, inclusive;
•Female subjects have a negative pregnancy test result prior to enrollment, and meet the following criteria defined as:
•If child-bearing potential, agree to avoid pregnancy during the study and one month after the end of the study by using at least one effective contraceptive method(s), such as an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives used for at least one month prior to screening, injectable progesterone, or progesterone sub-dermal implants.
•Surgically sterile for at least 3 months prior to screening by one of the following means:
•Bilateral tubal ligation
•Salpingectomy (with or without oophorectomy)
•Surgical hysterectomy
•Bilateral oophorectomy (with or without hysterectomy)
•Postmenopausal, defined as one of the following:

Exclusion Criteria

•Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
•Subjects with a mean systolic blood pressure of three measurements \>130 mmHG, or a mean diastolic blood pressure of three measurements \>90 mmHG at screening.
•History or presence of malignancy other than adequately treated basal cell skin cancer
•Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
•A history of seizure. However, a history of febrile seizure is allowed;
•Positive pregnancy test result, or plan to be pregnant if female;
•A hospital admission or major surgery within 30 days prior to screening;
•Participation in any other investigational drug trial within 30 days from the last dosing of other trials to screening;
•A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
•A history of alcohol abuse according to medical history within 6 months prior to screening;