Pilot BA Study of New LY03005 vs Pristiq

A Randomized, Open-Label, Single-Dose Study to Assess the Relative Bioavailability of LY03005 Oral Tablets Versus Pristiq Oral Tablets Under Fasting Conditions in Healthy Subjects

The objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005 oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under fasting conditions in healthy subjects between 18 and 50 years of age.

Study Overview

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

Detailed Description

Twenty (20) eligible subjects will be enrolled and assigned to either LY03005 group or Pristiq group at a 1:1 ratio at one site in the USA.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Clinilabs, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Are capable of giving informed consent and complying with study procedures;
2. Male and female subjects between the ages of 18 and 50 years;
3. Considered healthy by the Principal 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 in more than 6 months before screening based on subject report;
5. Body mass index (BMI) of 19 to 30 kg/m 2 inclusive and body weight not less than 50 kg;
6. Willing and able to adhere to study restrictions and to be confined at the clinical research center.
7. All female subjects no matter of age must have a negative pregnancy test result at screening. In addition, female subjects must meet one of the following three conditions: (i) postmenopausal for at least 2 years, (ii) surgically sterile based on subject report, or (iii) if child-bearing potential, practicing or agree to practice an effective method of birth control by using an acceptable method of contraception.

Acceptable methods of birth control include oral, injected, vaginal or patch contraceptive, IUD (Intrauterine device)(copper intrauterine device), or double- barrier method (e.g., condom, diaphragm or cervical cap with spermicidal foam, cream, gel or suppository). Acceptable methods of birth control must be used for at least 14 days prior to the use of study drug, during the study and within one month after the end of the study.

Exclusion Criteria:

1. Clinically significant past history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, ophthalmological, or drug hypersensitivity;
2. History of suicide attempt in the past 12 months and/or seen by the investigators having a significant history of risk of suicide or homicide;
3. History or presence of malignancy other than adequately treated basal cell skin cancer;
4. Clinically relevant illness within one month prior to the screening visit or at screening visit that may interfere with the conduct of this study;
5. Subjects with a mean systolic blood pressure of three measurements >140 mmHg, or a mean diastolic blood pressure of three measurements >90 mmHg at screening;
6. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
7. A history of seizure. However, a history of febrile seizure is allowed;
8. A hospital admission or major surgery within 30 days prior to screening;
9. Participation in any other investigational drug trial within 30 days prior to screening;
10. A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
11. A history of alcohol abuse according to medical history within 6 months prior to screening;
12. A positive screen for alcohol, drugs of abuse;
13. Tobacco use within 6 months prior to screening based on subject report;
14. Subjects with hypersensitivity to PRISTIQ or medicines containing desvenlafaxine or its precursor venlafaxine;
15. Subjects who have participated in a previous clinical study of either LY03005 or PRISTIQ or medicines containing desvenlafaxine or its precursor, venlafaxine within 30 days prior to screening;
16. An unwillingness or inability to comply with food and beverage restrictions during study participation;
17. 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;
18. 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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY03005; LY03005 80 mg	Drug: LY03005; LY03005
Active Comparator: Pristiq; Pristiq 50 mg	Drug: Pristiq; Other Names: Desvenlafaxine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under curve (AUC) for the Pharmacokinetics (PK) of LY03005	PK Samples drawn at 0 (within 30 minutes prior to dosing), 1,2,3,4 (+/- 5 min), 6,8,10,12,23,32,48 and 72 hours (+/- 15 min) after dosing.	4 days

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.
• Investigators: Study Chair: Simon Li, M.D., Luye Pharma Group Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2016
• Primary Completion (Actual): December 28, 2016
• Study Completion (Actual): December 28, 2016

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; 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-103