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

NCT02271412 | Completed Phase 1 DMC

• 2 other identifiers: LY03005 MADLY03005/CT-USA-102
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder, Recurrent, Unspecified

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Safety and Tolerability of LY03005

  3 to 4 months

Study Arms (2)

LY03005

EXPERIMENTAL

LY03005 40, 80, 120, or 160 mg

Drug: LY03005

Placebo

PLACEBO COMPARATOR

Placebo at 40, 80, 120, or 160 mg

Drug: Placebo

Interventions

LY03005 DRUG

LY03005 is a new investigational pro-drug of desvenlafaxine formulated as extended-release oral tablets for the treatment of major depressive disorder.

Also known as: 4-Methylbenzoate of desvenlafaxine hydrochloride

LY03005

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are capable of giving informed consent and complying with study procedures;
• Are between the ages of 18 and 45 years, inclusive;
• A negative pregnancy test result prior to screening and admission for all female subjects, and meet the following criteria defined as:
• 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.
• Surgically sterile for at least 3 months prior to screening
• Postmenopausal
• Considered healthy 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;
• Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg;
• Willing and able to adhere to study restrictions and to be confined at the clinical research center.

You may not qualify if:

• Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
• 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.
• Known or suspected malignancy;
• Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus;
• A history of seizure. However, a history of febrile seizure is allowed;
• Positive pregnancy test result, or plan to become pregnant if female;
• 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;
• DSM-V substance use disorder within 6 months prior to screening;
• A positive result for alcohol or drugs of abuse at screening or admission;
• Tobacco use within 6 months prior to screening;
• An unwillingness or inability to comply with food and beverage restrictions during study participation;
• 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;
• 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);
• A history of intolerance or hypersensitivity to venlafaxine or desvenlafaxine or any excipients;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

PRA Health Sciences

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Krefetz, MD

  PRA - CRI Lifetree

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

US (1)