Major Depressive DisorderPhase 1NCT03733574
A Study of LY03005 vs Pristiq
A Phase 1 study testing LY03005 and Pristiq in people with Major Depressive Disorder, run by Luye Pharma Group Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- LY03005 and Pristiq
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 26 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of giving informed consent and complying with trial procedures;
- Male and female subjects between the ages of 18 and 50 years, inclusive;
- Considered healthy by the 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 for at least 6 months before Screening based on subject report;
- 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 trial procedures and to be confined at the clinical research unit (CRU).
- All female subjects (childbearing potential and non-childbearing potential) must have a negative serum pregnancy test result at Screening. In addition, female subjects must meet 1 of the following 3 conditions: (i) postmenopausal for at least 12 months without an alternative medical cause, (ii) surgically sterile (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal occlusion) based on subject report, or (iii) if of childbearing potential and heterosexually active, practicing or agree to practice a highly effective method of contraception. Highly effective methods of birth control include an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), and contraceptives (oral, skin patches, or implanted or injectable products) using combined or progestogen-only hormonal contraception associated with inhibition of ovulation. A vasectomized male partner is an acceptable birth control method if the vasectomized partner is the sole sexual partner of the female subject and the vasectomized partner has received medical confirmation of surgical success.
- Highly effective methods of birth control must be used for at least 14 days prior to study drug dosing, through the end of study (EOS) visit or early termination, and for a minimum of 1 month after the last dose of study drug to minimize the risk of pregnancy. Sexually active, fertile, male subjects must be willing to use acceptable contraception methods (such as double-barrier methods of a combination of male condom with either cap, diaphragm, or sponge with spermicide) from the first dose of study drug through the EOS visit or early termination, and for a minimum of 1 month after the last dose of study drug.
Who cannot join
- Clinically significant past medical history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric (including life-long history of depression and/or anxiety), renal, hepatic, bronchopulmonary, neurologic, immunologic, ophthalmological, or lipid metabolism disorders; or drug hypersensitivity; or any other condition that in the judgement of the Investigator will affect the trial results or the subject's safety;
- 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;
- History or presence of malignancy other than adequately treated and cured basal cell carcinoma or squamous cell carcinoma (skin cancer);
- Clinically relevant illness within 1 month prior to Screening or at Screening that may interfere with the conduct of this trial;
- Medically uncontrolled high blood pressure with mean systolic blood pressure >140 mmHg or mean diastolic blood pressure >90 mmHg at Screening after 3 measurements (after at least 5 minutes of rest in a seated position);
- History of Long QT Syndrome (LQTS) or a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
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- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
- History of seizure (history of febrile seizure allowed);
- Hospital admission or major surgery within 30 days prior to Screening;
- Participation in any other investigational drug trial within 30 days prior to Screening;
- History of prescription drug abuse or illicit drug use within 6 months prior to Screening;
- History of alcohol abuse according to medical history within 6 months prior to Screening;
- Positive screen for alcohol and/or drugs of abuse;
- Tobacco use within 6 months prior to Screening based on positive nicotine screen;
- History of intolerance or hypersensitivity to ODV or medicines containing ODV or its precursor venlafaxine;
- Participation in a previous clinical trial 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 trial participation;
- Donation of blood of more than 1 unit (approximate 450 mL) 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/or herbals (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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, 2-Treatment, 2-Sequence, 2-Period Crossover Trial to Assess the Bioequivalence of 80 mg LY03005 to 50 mg Pristiq After Single Dose Administration Under Fasting Conditions to Healthy Subjects
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.
Read the detailed description
Fifty six (56) eligible subjects will be enrolled and assigned to either Group A or Group B at a 1:1 ratio.
- Conditions
- Major Depressive Disorder
- Being tested
- LY03005, Pristiq
- 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
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03005Drug
Drug: LY03005 80 mg, oral tablets, single dose
PristiqDrug
Also called Desvenlafaxine
Drug: Pristiq 50 mg, oral tablets, single dose
| Study group | Role | What they receive |
|---|---|---|
| LY03005 cross-over to Pristiq® (Desvenlafaxine) | Experimental | Subjects in this group will receive an 80 mg oral dose of LY03005. 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®). Receives: Drug: LY03005; Drug: Pristiq |
| Pristiq® (Desvenlafaxine) cross-over to LY03005 | Experimental | Subjects in this group will receive a 50 mg oral dose of desvenlafaxine (Pristiq®) After a washout period of up to 4 days, the subjects will be switched and will receive an 80 mg oral dose of LY03005 Receives: Drug: LY03005; Drug: Pristiq |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration-time curve (AUC)
Plasma ODV area under the concentration-time curve (AUC)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start19 Jun 2018
- Primary completion17 Jul 2018
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Sun, MD, PhD, MBA, Study chair, Luye Pharma Group Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733574
- Sponsor's protocol ID
- LY03005/CT-USA-106
- Status last verified
- Nov 2018
- First submitted
- 24 Jul 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, 2-Treatment, 2-Sequence, 2-Period Crossover Trial to Assess the Bioequivalence of 80 mg LY03005 to 50 mg Pristiq After Single Dose Administration Under Fasting Conditions to Healthy Subjects
- ClinicalTrials.gov ID
- NCT03733574
- Acronym / sponsor ID
- LY03005/CT-USA-106
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fifty six (56) eligible subjects will be enrolled and assigned to either Group A or Group B at a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY03005 cross-over to Pristiq® (Desvenlafaxine) | Experimental | Drug: LY03005, Drug: PristiqSubjects in this group will receive an 80 mg oral dose of LY03005. 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®). |
| Pristiq® (Desvenlafaxine) cross-over to LY03005 | Experimental | Drug: LY03005, Drug: PristiqSubjects in this group will receive a 50 mg oral dose of desvenlafaxine (Pristiq®) After a washout period of up to 4 days, the subjects will be switched and will receive an 80 mg oral dose of LY03005 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Capable of giving informed consent and complying with trial procedures;
- Male and female subjects between the ages of 18 and 50 years, inclusive;
- Considered healthy by the 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 for at least 6 months before Screening based on subject report;
- Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg;
Key exclusion criteria (19 listed)
- Clinically significant past medical history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric (including life-long history of depression and/or anxiety), renal, hepatic, bronchopulmonary, neurologic, immunologic, ophthalmological, or lipid metabolism disorders; or drug hypersensitivity; or any other condition that in the judgement of the Investigator will affect the trial results or the subject's safety;
- 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;
- History or presence of malignancy other than adequately treated and cured basal cell carcinoma or squamous cell carcinoma (skin cancer);
- Clinically relevant illness within 1 month prior to Screening or at Screening that may interfere with the conduct of this trial;
- Medically uncontrolled high blood pressure with mean systolic blood pressure >140 mmHg or mean diastolic blood pressure >90 mmHg at Screening after 3 measurements (after at least 5 minutes of rest in a seated position);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY03005Drug: LY03005 80 mg, oral tablets, single dose | Drug | LY03005 cross-over to Pristiq® (Desvenlafaxine), Pristiq® (Desvenlafaxine) cross-over to LY03005 |
| PristiqAlso: DesvenlafaxineDrug: Pristiq 50 mg, oral tablets, single dose | Drug | LY03005 cross-over to Pristiq® (Desvenlafaxine), Pristiq® (Desvenlafaxine) cross-over to LY03005 |
Primary outcome
concentration-time curve (AUC)
Time frame: 15 days
Plasma ODV area under the concentration-time curve (AUC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Drug informationLink provided by the sponsor.
- DesvenlafaxineLink provided by the sponsor.
- Desvenlafaxine SuccinateLink provided by the sponsor.
- U.S. FDA ResourcesLink provided by the sponsor.
- Pristiq (Desvenlafaxine) Label - FDALink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Sun, MD, PhD, MBA study chair
Luye Pharma Group Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY03005 and Pristiq in people with Major Depressive Disorder, run by Luye Pharma Group Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration-time curve (AUC) (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.