Major Depressive DisorderPhase 1NCT03822065
A Relative Bioavailability Food Effect Study of LY03005
A Phase 1 study testing LY03005 in people with Major Depressive Disorder, run by Luye Pharma Group Ltd. at 1 site in United States.
Trial summary
The objective if this study is to assess the relative bio-availability of single oral doses of 80 mg LY03005 tablets administered to healthy subjects under fed versus fasted conditions in a 2-period, crossover trial. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 16 Feb 2019
- 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 >/= 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: (a) 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 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 skin cancer, squamous cell skin cancer, or in-situ cervical cancer, within 5 years prior to screening;
- 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);
Show all 19Show fewer
- Positive blood screen for 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 subject report or 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 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-Period, Crossover Trial to Assess the Relative Bioavailability of 80 mg LY03005 After Single Dose Administration to Healthy Subjects Under Fed Versus Fasted Conditions
The objective if this study is to assess the relative bio-availability of single oral doses of 80 mg LY03005 tablets administered to healthy subjects under fed versus fasted conditions in a 2-period, crossover trial.
Read the detailed description
Thirty-two (32) eligible healthy subjects between ages of 18-50 years old will be enrolled and randomized to either Sequence 1 (fed to fasted state) versus Sequence 2 (fasted to fed state) at a 1:1 ratio.
- Conditions
- Major Depressive Disorder
- Being tested
- LY03005
- 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
Also called Desvenlafaxine
80 mg oral tablet single dose
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: LY03005 Fed Crossover to Fasted | Experimental | Sequence 1 will receive a single oral dose of LY03005 (80 mg) under fed conditions in Treatment Period 1 and a single oral dose of LY03005 (80 mg) under fasted conditions in Treatment Period 2. Receives: Drug: LY03005 |
| Sequence 2: LY03005 Fasted Crossover to Fed | Experimental | Sequence 2 will receive a single oral dose of LY03005 (80 mg) under fasted conditions in Treatment Period 1 and a single oral dose of LY03005 (80 mg) under fed conditions in Treatment Period 2. Receives: Drug: LY03005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters
Area under the concentration-time curve (AUC)
Measured: PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose.
Pharmacokinetic Parameters
Maximum concentration (Cmax) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005
Measured: PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start16 Jan 2019
- Primary completion16 Feb 2019
- Study completion16 Feb 2019
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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Booth, MD, DVM, Study director, Luye Pharma.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822065
- Sponsor's protocol ID
- LY03005/CT-USA-105
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- 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 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, 2-Period, Crossover Trial to Assess the Relative Bioavailability of 80 mg LY03005 After Single Dose Administration to Healthy Subjects Under Fed Versus Fasted Conditions
- ClinicalTrials.gov ID
- NCT03822065
- Acronym / sponsor ID
- LY03005/CT-USA-105
- 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
- 34 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 16 Feb 2019 (actual)
- Study completion
- 16 Feb 2019 (actual)
- First posted
- 30 Jan 2019 (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 if this study is to assess the relative bio-availability of single oral doses of 80 mg LY03005 tablets administered to healthy subjects under fed versus fasted conditions in a 2-period, crossover trial.
Detailed description
Thirty-two (32) eligible healthy subjects between ages of 18-50 years old will be enrolled and randomized to either Sequence 1 (fed to fasted state) versus Sequence 2 (fasted to fed state) 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 |
|---|---|---|
| Sequence 1: LY03005 Fed Crossover to Fasted | Experimental | Drug: LY03005Sequence 1 will receive a single oral dose of LY03005 (80 mg) under fed conditions in Treatment Period 1 and a single oral dose of LY03005 (80 mg) under fasted conditions in Treatment Period 2. |
| Sequence 2: LY03005 Fasted Crossover to Fed | Experimental | Drug: LY03005Sequence 2 will receive a single oral dose of LY03005 (80 mg) under fasted conditions in Treatment Period 1 and a single oral dose of LY03005 (80 mg) under fed conditions in Treatment Period 2. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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 >/= 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 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 skin cancer, squamous cell skin cancer, or in-situ cervical cancer, within 5 years prior to screening;
- 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 |
|---|---|---|
| LY03005Also: Desvenlafaxine80 mg oral tablet single dose | Drug | Sequence 1: LY03005 Fed Crossover to Fasted, Sequence 2: LY03005 Fasted Crossover to Fed |
Primary outcome
Pharmacokinetic Parameters
Time frame: PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose.
Area under the concentration-time curve (AUC)
Pharmacokinetic Parameters
Time frame: PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose.
Maximum concentration (Cmax) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005
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 6 Aug 2019.
- 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.
- 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.
Kevin Booth, MD, DVM study director
Luye Pharma.
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 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 7 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 6 Aug 2019. 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?
Pharmacokinetic Parameters (time frame: PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose.). The study lists 2 primary outcomes in all. 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 6 Aug 2019.