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Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005

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ClinicalTrials.gov Identifier: NCT02271412
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Luye Pharma Group Ltd.

Brief Summary:

Objectives

  • To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in healthy subjects.
  • To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder, Recurrent, Unspecified Drug: LY03005 Drug: Placebo Phase 1

Detailed Description:
This will be a randomized, double-blind, placebo-controlled, multiple ascending dose study to be conducted in the US. Approximately 48 healthy subjects will be enrolled into one of the four groups

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005
Study Start Date : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY03005
LY03005 40, 80, 120, or 160 mg
Drug: LY03005
LY03005 is a new investigational pro-drug of desvenlafaxine formulated as extended-release oral tablets for the treatment of major depressive disorder.
Other Name: 4-Methylbenzoate of desvenlafaxine hydrochloride

Placebo Comparator: Placebo
Placebo at 40, 80, 120, or 160 mg
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 3 to 4 months ]
    Safety and Tolerability of LY03005



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

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. A negative pregnancy test result prior to screening and admission for all female subjects, 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 effective contraceptive method(s), such as an intrauterine device (IUD), diaphragm with spermicide, and condoms with spermicide.
    2. Surgically sterile for at least 3 months prior to screening
    3. Postmenopausal
  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 30 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:

Subjects will be excluded from study entry if any of the following exclusion criteria are present at screening or admission:

  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 less than 130 mmHG, or a mean diastolic blood pressure of three measurements less than 90 mmHG at screening. Blood pressure will be measured at supine position.
  3. Known or suspected malignancy;
  4. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus;
  5. A history of seizure. However, a history of febrile seizure is allowed;
  6. Positive pregnancy test result, or plan to become 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 prior to screening;
  9. DSM-V substance use disorder within 6 months prior to screening;
  10. A positive result for alcohol or drugs of abuse at screening or admission;
  11. Tobacco use within 6 months prior to screening;
  12. An unwillingness or inability to comply with food and beverage restrictions during study participation;
  13. 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;
  14. Use of prescription or over-the-counter (OTC) medications, and herbal medicines (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);
  15. A history of intolerance or hypersensitivity to venlafaxine or desvenlafaxine or any excipients;
  16. A history of suicide attempt in the past 12 months and/or seen by the investigator as having a significant history of risk of suicide or homicide; 17 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 ClinicalTrials.gov identifier (NCT number): NCT02271412


Locations
United States, New Jersey
PRA Health Sciences
Marlton, New Jersey, United States, 08053
Sponsors and Collaborators
Luye Pharma Group Ltd.
Investigators
Principal Investigator: David Krefetz, MD PRA - CRI Lifetree

Responsible Party: Luye Pharma Group Ltd.
ClinicalTrials.gov Identifier: NCT02271412     History of Changes
Other Study ID Numbers: LY03005 MAD
LY03005/CT-USA-102 ( Other Identifier: Luye )
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Recurrence
Mood Disorders
Mental Disorders
Behavioral Symptoms
Disease Attributes
Pathologic Processes
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