Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®

NCT03357796 | Completed Phase 1 FDA Drug

• 1 other identifier: LY03005/CT-USA-104
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Depressive Disorder, Major; Depressive Disorder; Mood Disorders; Mental Disorders; 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse Events Assessment

  up to 35 days

Study Arms (2)

Group A: LY03005 cross-over to Pristiq®

EXPERIMENTAL

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; Drug: Pristiq

Group B: Pristiq® cross-over to LY03005

EXPERIMENTAL

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; Drug: Pristiq

Interventions

LY03005 DRUG

80 mg, oral tablets, single dose

Group A: LY03005 cross-over to Pristiq®; Group B: Pristiq® cross-over to LY03005

Pristiq DRUG

50 mg, oral tablets, single dose

Also known as: Desvenlafaxine

Group A: LY03005 cross-over to Pristiq®; Group B: Pristiq® cross-over to LY03005

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Capable of giving informed consent and complying with study procedures;
• Male and female subjects between the ages of 18 and 50 years;
• 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;
• Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before Screening based on subject report;
• Body mass index (BMI) of 19 to 28 kg/m2 inclusive and body weight not less than 50 kg;
• Willing and able to adhere to study procedures and to be confined at the clinical research center.
• 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.

You may not qualify if:

• 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;
• 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;
• History or presence of malignancy other than adequately treated and cured basal cell skin cancer;
• Clinically relevant illness within 1 month prior to the Screening Visit or at Screening Visit that may interfere with the conduct of this study;
• 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);
• Positive blood Screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
• A history of seizure. However, a history of febrile seizure is allowed;
• A hospital admission or major surgery within 30 days prior to Screening;
• Participation in any other investigational drug trial within 30 days prior to Screening;
• A history of prescription drug abuse or illicit drug use within 6 months prior to Screening;
• A history of alcohol abuse according to medical history within 6 months prior to Screening;
• A positive screen for alcohol and drugs of abuse;
• Subjects with hypersensitivity to ODV or medicines containing ODV or its precursor venlafaxine;
• 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;
• Unwillingness or inability to comply with food and beverage restrictions during study participation;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Clinilabs, Inc.

Eatontown, New Jersey, 07724, United States

Location

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder; Mood Disorders; Mental Disorders

Interventions

Desvenlafaxine Succinate

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Study Officials

• Amy Sun, MD, PhD, MBA

  Luye Pharma Group Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 30, 2017
• Study Start: November 27, 2017
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: January 4, 2018

Record last verified: 2017-11

Locations

US (1)