Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®

A Randomized, Open-label, Cross-over, 2-period Study to Assess the Relative Bioavailability Between 80 mg LY03005 Versus 50 mg Desvenlafaxine Comparator (Pristiq®) Under Fasting Condition After Single Dose Administration in 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

Twenty (20) eligible subjects will be enrolled and assigned to either Group A or Group B at a 1:1 ratio.

• 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: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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 as assessed 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 28 kg/m2 inclusive and body weight not less than 50 kg;
6. Willing and able to adhere to study procedures and to be confined at the clinical research center.
7. All female subjects no matter of age must have a negative serum pregnancy test result at Screening. In addition, female subjects must meet one of the following 3 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 intrauterine device (IUD), 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 1 month after the end of the study.

Exclusion Criteria:

1. Clinically significant past medical history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, ophthalmological, or drug hypersensitivity or any condition that in the judgement of the investigator will affect the study results or the subject's safety;
2. History of suicide attempt in the past 12 months and/or seen by the investigators 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 skin cancer;
4. Clinically relevant illness within 1 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 >140 mmHg or a mean diastolic blood pressure of >90 mmHg at Screening after 3 measurements (after 5 minutes of rest in a sitting position);
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 and drugs of abuse;
13. Subjects with hypersensitivity to ODV or medicines containing ODV or its precursor venlafaxine;
14. Subjects who have participated in a previous clinical study of either LY03005 or ODV or medicines containing ODV or its precursor, venlafaxine within 30 days prior to Screening;
15. Unwillingness or inability to comply with food and beverage restrictions during study participation;
16. 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;
17. Use of prescription or over-the-counter (OTC) medications, and 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
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A: LY03005 cross-over to Pristiq®; Subjects in Group A will receive an 80 mg oral dose of LY03005 and the subjects will stay in the CRU for 4 days (Period 1). 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®) comparator followed by a 4-day stay in the CRU (Period 2).	Drug: LY03005; 80 mg, oral tablets, single dose; Drug: Pristiq; 50 mg, oral tablets, single dose; Other Names: Desvenlafaxine
EXPERIMENTAL: Group B: Pristiq® cross-over to LY03005; Subjects in Group B will receive a 50 mg oral dose of desvenlafaxine (Pristiq®) comparator and the subjects will stay in the CRU for 4 days (Period 1). After a washout period of up to 4 days, the subjects will be switched and will receive an 80 mg oral dose of LY03005 followed by a 4-day stay in the CRU (Period 2).	Drug: LY03005; 80 mg, oral tablets, single dose; 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
Area under the concentration-time curve (AUC) Assessment	Area under the concentration-time curve (AUC) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005 and ODV from Pristiq will be determined.	PK Samples drawn at 0, 1,2,3,4, 6,8,10,12,24,32,48 and 72 hours after dosing in both Period 1 and Period 2.
Maximum concentration (Cmax) Assessment	Maximum concentration (Cmax) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005 and ODV from Pristiq will be determined.	PK Samples drawn at 0, 1,2,3,4, 6,8,10,12,24,32,48 and 72 hours after dosing in both Period 1 and Period 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Assessment	Collection of adverse events throughout the study as a measure of safety and tolerability.	up to 35 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): November 27, 2017
• Primary Completion (ACTUAL): December 22, 2017
• Study Completion (ACTUAL): December 22, 2017

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 24, 2017
• First Posted (ACTUAL): November 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 4, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: November 1, 2017

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-104

Drug and device information, study documents

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