Safety, Tolerability and Pharmacokinetics Study of LY03005

NCT02055300 | Completed Phase 1

• 1 other identifier: LY03005
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  11 Days

Secondary Outcomes (1)

• PK parameters of: Cmax,

  4 days

Study Arms (9)

LY03005 - 20

EXPERIMENTAL

LY03005 Dose Strength 20mg

Drug: LY03005; Drug: Placebo

LY03005 - 40

EXPERIMENTAL

LY03005 Dose Strength 40mg

Drug: LY03005; Drug: Placebo

LY03005- 80

EXPERIMENTAL

LY03005 Dose Strength 80mg

Drug: LY03005; Drug: Placebo

LY03005 - 120

EXPERIMENTAL

LY03005 Dose Strength 120mg

Drug: LY03005; Drug: Placebo

LY03005 - 160

EXPERIMENTAL

LY03005 Dose Strength 160 mg

Drug: LY03005; Drug: Placebo

LY03005 - 200

EXPERIMENTAL

LY03005 Dose Strength 200mg

Drug: LY03005; Drug: Placebo

LY03005 - 120 - Fed

EXPERIMENTAL

LY03005 120mg under Fed Conditions

Drug: LY03005; Other: Meal

Pristiq

ACTIVE COMPARATOR

Pristiq - 50mg

Drug: Pristiq

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

LY03005 DRUG

LY03005 - 120; LY03005 - 120 - Fed; LY03005 - 160; LY03005 - 20; LY03005 - 200; LY03005 - 40; LY03005- 80

Placebo DRUG

LY03005 - 120; LY03005 - 160; LY03005 - 20; LY03005 - 200; LY03005 - 40; LY03005- 80; Placebo

Meal OTHER

LY03005 - 120 - Fed

Pristiq DRUG

Pristiq

Eligibility Criteria

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

You may qualify if:

• 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:
• Last menstrual period greater than 12 months prior to screening
• Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;
• Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening;
• Body mass index (BMI) of 19 to 32 kg/m2 inclusive and body weight not less than 50 kg;
• Willing and able to adhere to study restrictions and to be confined at the clinical research center.

You may not qualify if:

• 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;
• A positive screen for alcohol, drugs of abuse;
• Tobacco use within 6 months prior to screening;
• An unwillingness or inability to comply with food and beverage restrictions during study participation;
• Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;
• Use of prescription or over-the-counter (OTC) medications, and herbal (including St John's Wort, herbal teas, garlic extracts)within 14 days prior to dosing (Note: Use of acetaminophen at \< 3g/day is permitted until 24 hours prior to dosing);

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Medpace

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Meals; Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Study Officials

• Simon Li

  Luye Pharma Group Ltd.

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 5, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 10, 2014

Record last verified: 2014-11

Locations

US (1)