Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005
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|ClinicalTrials.gov Identifier: NCT02271412|
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : October 21, 2015
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder, Recurrent, Unspecified||Drug: LY03005 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005|
|Study Start Date :||October 2014|
|Primary Completion Date :||March 2015|
|Study Completion Date :||March 2015|
LY03005 40, 80, 120, or 160 mg
LY03005 is a new investigational pro-drug of desvenlafaxine formulated as extended-release oral tablets for the treatment of major depressive disorder.
Other Name: 4-Methylbenzoate of desvenlafaxine hydrochloride
Placebo Comparator: Placebo
Placebo at 40, 80, 120, or 160 mg
- Number of Participants With Adverse Events [ Time Frame: 3 to 4 months ]Safety and Tolerability of LY03005
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271412
|United States, New Jersey|
|PRA Health Sciences|
|Marlton, New Jersey, United States, 08053|
|Principal Investigator:||David Krefetz, MD||PRA - CRI Lifetree|