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Safety, Tolerability and Pharmacokinetics Study of LY03005 (LY03005SAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02055300
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : November 10, 2014
Information provided by (Responsible Party):
Luye Pharma Group Ltd.

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: LY03005 Drug: Placebo Other: Meal Drug: Pristiq Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03005
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LY03005 - 20
LY03005 Dose Strength 20mg
Drug: LY03005
Drug: Placebo
Experimental: LY03005 - 40
LY03005 Dose Strength 40mg
Drug: LY03005
Drug: Placebo
Experimental: LY03005- 80
LY03005 Dose Strength 80mg
Drug: LY03005
Drug: Placebo
Experimental: LY03005 - 120
LY03005 Dose Strength 120mg
Drug: LY03005
Drug: Placebo
Experimental: LY03005 - 160
LY03005 Dose Strength 160 mg
Drug: LY03005
Drug: Placebo
Experimental: LY03005 - 200
LY03005 Dose Strength 200mg
Drug: LY03005
Drug: Placebo
Experimental: LY03005 - 120 - Fed
LY03005 120mg under Fed Conditions
Drug: LY03005
Other: Meal
Active Comparator: Pristiq
Pristiq - 50mg
Drug: Pristiq
Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 11 Days ]

Secondary Outcome Measures :
  1. PK parameters of: Cmax, [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Are capable of giving informed consent and complying with study procedures;
  2. Are between the ages of 18 and 45 years, inclusive;
  3. Female subjects have a negative pregnancy test result prior to enrollment, and meet the following criteria defined as:

    1. 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.
    2. 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)
    3. Postmenopausal, defined as one of the following:

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

Exclusion Criteria:

  1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
  2. 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.
  3. History or presence of malignancy other than adequately treated basal cell skin cancer
  4. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
  5. A history of seizure. However, a history of febrile seizure is allowed;
  6. Positive pregnancy test result, or plan to be pregnant if female;
  7. A hospital admission or major surgery within 30 days prior to screening;
  8. Participation in any other investigational drug trial within 30 days from the last dosing of other trials to screening;
  9. A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
  10. A history of alcohol abuse according to medical history within 6 months prior to screening;
  11. A positive screen for alcohol, drugs of abuse;
  12. Tobacco use within 6 months prior to screening;
  13. An unwillingness or inability to comply with food and beverage restrictions during study participation;
  14. 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;
  15. 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);
  16. A history of intolerance or hypersensitivity to venlafaxine or desvenlafaxine or any excipients;
  17. Patients with a history of suicide attempt in the past 6 months and/or seen by the investigator as having a significant history of risk of suicide or homicide;
  18. An unwillingness of male participants to use appropriate contraceptive measures if engaging in sex intercourse with a female partner of childbearing potential. Appropriate measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone sub-dermal implants, or a tubal ligation. Sexual intercourse with pregnant or lactating women is prohibited.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02055300

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United States, Ohio
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Luye Pharma Group Ltd.
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Study Chair: Simon Li Luye Pharma Group Ltd.

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Responsible Party: Luye Pharma Group Ltd. Identifier: NCT02055300    
Other Study ID Numbers: LY03005
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs