A Study of LY03005 vs Pristiq

A Randomized, Open-Label, 2-Treatment, 2-Sequence, 2-Period Crossover Trial to Assess the Bioequivalence of 80 mg LY03005 to 50 mg Pristiq After Single Dose Administration Under Fasting Conditions to Healthy Subjects

The objective of this study is to evaluate relative bioavailability between 80 mg LY03005 oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over 2-period design under fasting condition in healthy subjects between 18 and 50 years of age.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: LY03005; Drug: Pristiq

Detailed Description

Fifty six (56) eligible subjects will be enrolled and assigned to either Group A or Group B at a 1:1 ratio.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron CPC, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Capable of giving informed consent and complying with trial procedures;
2. Male and female subjects between the ages of 18 and 50 years, inclusive;
3. Considered healthy by the Investigator based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
4. Nonsmoker, defined as not having smoked or used any form of tobacco for at least 6 months before Screening based on subject report;
5. Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg;
6. Willing and able to adhere to trial procedures and to be confined at the clinical research unit (CRU).
7. All female subjects (childbearing potential and non-childbearing potential) must have a negative serum pregnancy test result at Screening. In addition, female subjects must meet 1 of the following 3 conditions: (i) postmenopausal for at least 12 months without an alternative medical cause, (ii) surgically sterile (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal occlusion) based on subject report, or (iii) if of childbearing potential and heterosexually active, practicing or agree to practice a highly effective method of contraception. Highly effective methods of birth control include an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), and contraceptives (oral, skin patches, or implanted or injectable products) using combined or progestogen-only hormonal contraception associated with inhibition of ovulation. A vasectomized male partner is an acceptable birth control method if the vasectomized partner is the sole sexual partner of the female subject and the vasectomized partner has received medical confirmation of surgical success.

Highly effective methods of birth control must be used for at least 14 days prior to study drug dosing, through the end of study (EOS) visit or early termination, and for a minimum of 1 month after the last dose of study drug to minimize the risk of pregnancy. Sexually active, fertile, male subjects must be willing to use acceptable contraception methods (such as double-barrier methods of a combination of male condom with either cap, diaphragm, or sponge with spermicide) from the first dose of study drug through the EOS visit or early termination, and for a minimum of 1 month after the last dose of study drug.

Exclusion Criteria:

1. Clinically significant past medical history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric (including life-long history of depression and/or anxiety), renal, hepatic, bronchopulmonary, neurologic, immunologic, ophthalmological, or lipid metabolism disorders; or drug hypersensitivity; or any other condition that in the judgement of the Investigator will affect the trial results or the subject's safety;
2. 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;
3. History or presence of malignancy other than adequately treated and cured basal cell carcinoma or squamous cell carcinoma (skin cancer);
4. Clinically relevant illness within 1 month prior to Screening or at Screening that may interfere with the conduct of this trial;
5. Medically uncontrolled high blood pressure with mean systolic blood pressure >140 mmHg or mean diastolic blood pressure >90 mmHg at Screening after 3 measurements (after at least 5 minutes of rest in a seated position);
6. History of Long QT Syndrome (LQTS) or a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
7. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
8. History of seizure (history of febrile seizure allowed);
9. Hospital admission or major surgery within 30 days prior to Screening;
10. Participation in any other investigational drug trial within 30 days prior to Screening;
11. History of prescription drug abuse or illicit drug use within 6 months prior to Screening;
12. History of alcohol abuse according to medical history within 6 months prior to Screening;
13. Positive screen for alcohol and/or drugs of abuse;
14. Tobacco use within 6 months prior to Screening based on positive nicotine screen;
15. History of intolerance or hypersensitivity to ODV or medicines containing ODV or its precursor venlafaxine;
16. Participation in a previous clinical trial of either LY03005 or ODV or medicines containing ODV or its precursor, venlafaxine, within 30 days prior to Screening;
17. Unwillingness or inability to comply with food and beverage restrictions during trial participation;
18. Donation of blood of more than 1 unit (approximate 450 mL) or blood products or acute loss of blood during the 90 days prior to Screening;
19. Use of prescription or over-the-counter (OTC) medications and/or herbals (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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY03005 cross-over to Pristiq® (Desvenlafaxine); Subjects in this group will receive an 80 mg oral dose of LY03005. After a washout period of up to 4 days, the subjects will be switched and will receive a 50 mg oral dose of desvenlafaxine (Pristiq®).	Drug: LY03005; Drug: LY03005 80 mg, oral tablets, single dose; Drug: Pristiq; Drug: Pristiq 50 mg, oral tablets, single dose; Other Names: Desvenlafaxine
Experimental: Pristiq® (Desvenlafaxine) cross-over to LY03005; Subjects in this group will receive a 50 mg oral dose of desvenlafaxine (Pristiq®) After a washout period of up to 4 days, the subjects will be switched and will receive an 80 mg oral dose of LY03005	Drug: LY03005; Drug: LY03005 80 mg, oral tablets, single dose; Drug: Pristiq; Drug: Pristiq 50 mg, oral tablets, single dose; Other Names: Desvenlafaxine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concentration-time curve (AUC)	Plasma ODV area under the concentration-time curve (AUC)	15 days

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.

Publications and helpful links

Helpful Links

• U.S. FDA Resources
• Drug information
• Desvenlafaxine
• Desvenlafaxine Succinate
• Pristiq (Desvenlafaxine) Label - FDA

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): July 17, 2018
• Study Completion (Actual): July 26, 2018

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 7, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Mood Disorders; Depressive Disorder; Physiological Effects of Drugs; Mental Disorders; Depressive Disorder, Major; Antidepressive Agents; Psychotropic Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin and Noradrenaline Reuptake Inhibitors; Membrane Transport Modulators; Neurotransmitter Uptake Inhibitors; Desvenlafaxine Succinate
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Desvenlafaxine Succinate
• Other Study ID Numbers: LY03005/CT-USA-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No