A Phase 1 interventional study of LY03005 and Placebo in Major Depressive Disorder, sponsored by Luye Pharma Group Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-10.
Sponsored by Luye Pharma Group Ltd. · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety and tolerability of escalating single oral doses of LY03005 in healthy subjects and to characterize the pharmacokinetics (PK) of escalating single oral doses of LY03005.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 88 is close to the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Luye Pharma Group Ltd. is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female subjects have a negative pregnancy test result prior to enrollment, and meet the following criteria defined as:
Surgically sterile for at least 3 months prior to screening by one of the following means:
Postmenopausal, defined as one of the following:
Exclusion Criteria:
LY03005 Dose Strength 20mg
Drug: LY03005 · Drug: Placebo
LY03005 Dose Strength 40mg
Drug: LY03005 · Drug: Placebo
LY03005 Dose Strength 80mg
Drug: LY03005 · Drug: Placebo
LY03005 Dose Strength 120mg
Drug: LY03005 · Drug: Placebo
LY03005 Dose Strength 160 mg
Drug: LY03005 · Drug: Placebo
LY03005 Dose Strength 200mg
Drug: LY03005 · Drug: Placebo
LY03005 120mg under Fed Conditions
Drug: LY03005 · Other: Meal
Pristiq - 50mg
Drug: Pristiq
Placebo
Drug: Placebo
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 11 Days
PK parameters of: Cmax,
Time frame: 4 days
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Luye Pharma Group Ltd.