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CompletedNCT02055300LY03005SADUpdated Nov 10, 2014

Safety, Tolerability and Pharmacokinetics Study of LY03005

A Phase 1 interventional study of LY03005 and Placebo in Major Depressive Disorder, sponsored by Luye Pharma Group Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-10.

Sponsored by Luye Pharma Group Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 88 is close to the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Luye Pharma Group Ltd. is the lead sponsor of 72 studies on the registry; 15 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • 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

    Placebo

    Drug: Placebo

Interventions

  • DrugLY03005
  • DrugPlacebo
  • OtherMeal
  • DrugPristiq
06

What researchers measure

Primary outcomes

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

    Time frame: 11 Days

Secondary outcomes

  1. PK parameters of: Cmax,

    Time frame: 4 days

07

Study locations

1 site
  • Medpace
    Cincinnati, Ohio 45227, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02055300
Lead sponsor
Luye Pharma Group Ltd.
Responsible party
Sponsor
First posted
Feb 5, 2014
Start date
Feb 2014
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Nov 10, 2014

Study contacts

Simon Li
study chair · Luye Pharma Group Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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