Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005
Status: | Completed |
---|---|
Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 4/21/2016 |
Start Date: | October 2014 |
End Date: | March 2015 |
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005
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.
- 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.
This will be a randomized, double-blind, placebo-controlled, multiple ascending dose study
to be conducted in the US. Approximately 48 healthy subjects will be enrolled into one of
the four groups
to be conducted in the US. Approximately 48 healthy subjects will be enrolled into one of
the four groups
Inclusion Criteria:
1. Are capable of giving informed consent and complying with study procedures;
2. Are between the ages of 18 and 45 years, inclusive;
3. A negative pregnancy test result prior to screening and admission for all female
subjects, and meet the following criteria defined as:
1. 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.
2. Surgically sterile for at least 3 months prior to screening
3. Postmenopausal
4. Considered healthy by the Principal Investigator, based on a detailed medical
history, full physical examination, clinical laboratory tests, 12-lead ECG and vital
signs;
5. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6
months before screening;
6. Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50
kg;
7. Willing and able to adhere to study restrictions and to be confined at the clinical
research center.
Exclusion Criteria:
Subjects will be excluded from study entry if any of the following exclusion criteria are
present at screening or admission:
1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,
endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,
immunologic, lipid metabolism disorders, or drug hypersensitivity;
2. 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.
3. Known or suspected malignancy;
4. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface
antigen (HBsAg), or hepatitis C virus;
5. A history of seizure. However, a history of febrile seizure is allowed;
6. Positive pregnancy test result, or plan to become pregnant if female;
7. A hospital admission or major surgery within 30 days prior to screening;
8. Participation in any other investigational drug trial within 30 days prior to
screening;
9. DSM-V substance use disorder within 6 months prior to screening;
10. A positive result for alcohol or drugs of abuse at screening or admission;
11. Tobacco use within 6 months prior to screening;
12. An unwillingness or inability to comply with food and beverage restrictions during
study participation;
13. 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;
14. 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);
15. A history of intolerance or hypersensitivity to venlafaxine or desvenlafaxine or any
excipients;
16. A 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; 17 An unwillingness of
male participants to use appropriate contraceptive measures if engaging in sex
intercourse with a female partner of childbearing potential. Appropriate measures
include use of a condom and spermicide and, for female partners, use of an
intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable
progesterone, progesterone sub-dermal implants, or a tubal ligation. Sexual
intercourse with pregnant or lactating women is prohibited.
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