Major Depressive DisorderPhase 1NCT03357796
Relative Bioavailability (RBA) 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 22 Dec 2017
- 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 study procedures;
- Male and female subjects between the ages of 18 and 50 years;
- Considered healthy as assessed by the principal 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 in more than 6 months before Screening based on subject report;
- Body mass index (BMI) of 19 to 28 kg/m2 inclusive and body weight not less than 50 kg;
- Willing and able to adhere to study procedures and to be confined at the clinical research center.
- All female subjects no matter of age must have a negative serum pregnancy test result at Screening. In addition, female subjects must meet one of the following 3 conditions: (i) postmenopausal for at least 2 years, (ii) surgically sterile based on subject report, or (iii) if child-bearing potential, practicing or agree to practice an effective method of birth control by using an acceptable method of contraception. Acceptable methods of birth control include intrauterine device (IUD), or double-barrier method (e.g., condom, diaphragm or cervical cap with spermicidal foam, cream, gel or suppository). Acceptable methods of birth control must be used for at least 14 days prior to the use of study drug during the study and within 1 month after the end of the study.
Who cannot join
- Clinically significant past medical history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, ophthalmological, or drug hypersensitivity or any condition that in the judgement of the investigator will affect the study results or the subject's safety;
- History of suicide attempt in the past 12 months and/or seen by the investigators 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;
- Clinically relevant illness within 1 month prior to the Screening Visit or at Screening Visit that may interfere with the conduct of this study;
- Subjects with a mean systolic blood pressure >140 mmHg or a mean diastolic blood pressure of >90 mmHg at Screening after 3 measurements (after 5 minutes of rest in a sitting position);
- Positive blood Screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
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- A history of seizure. However, a history of febrile seizure is allowed;
- A hospital admission or major surgery within 30 days prior to Screening;
- Participation in any other investigational drug trial within 30 days prior to Screening;
- A history of prescription drug abuse or illicit drug use within 6 months prior to Screening;
- A history of alcohol abuse according to medical history within 6 months prior to Screening;
- A positive screen for alcohol and drugs of abuse;
- Subjects with hypersensitivity to ODV or medicines containing ODV or its precursor venlafaxine;
- Subjects who have participated in a previous clinical study 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 study 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, Cross-over, 2-period Study to Assess the Relative Bioavailability Between 80 mg LY03005 Versus 50 mg Desvenlafaxine Comparator (Pristiq®) Under Fasting Condition After Single Dose Administration in 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
Twenty (20) 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
80 mg, oral tablets, single dose
PristiqDrug
Also called Desvenlafaxine
50 mg, oral tablets, single dose
| Study group | Role | What they receive |
|---|---|---|
| Group A: LY03005 cross-over to Pristiq® | Experimental | Subjects in Group A will receive an 80 mg oral dose of LY03005 and the subjects will stay in the CRU for 4 days (Period 1). 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®) comparator followed by a 4-day stay in the CRU (Period 2). Receives: Drug: LY03005; Drug: Pristiq |
| Group B: Pristiq® cross-over to LY03005 | Experimental | Subjects in Group B will receive a 50 mg oral dose of desvenlafaxine (Pristiq®) comparator and the subjects will stay in the CRU for 4 days (Period 1). After a washout period of up to 4 days, the subjects will be switched and will receive an 80 mg oral dose of LY03005 followed by a 4-day stay in the CRU (Period 2). Receives: Drug: LY03005; Drug: Pristiq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) Assessment
Area under the concentration-time curve (AUC) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005 and ODV from Pristiq will be determined.
Measured: PK Samples drawn at 0, 1,2,3,4, 6,8,10,12,24,32,48 and 72 hours after dosing in both Period 1 and Period 2.
Maximum concentration (Cmax) Assessment
Maximum concentration (Cmax) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005 and ODV from Pristiq will be determined.
Measured: PK Samples drawn at 0, 1,2,3,4, 6,8,10,12,24,32,48 and 72 hours after dosing in both Period 1 and Period 2.
Secondary outcomes (1)
Adverse Events Assessment
Collection of adverse events throughout the study as a measure of safety and tolerability.
Measured: up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start27 Nov 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
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
- 20 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
- NCT03357796
- Sponsor's protocol ID
- LY03005/CT-USA-104
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Cross-over, 2-period Study to Assess the Relative Bioavailability Between 80 mg LY03005 Versus 50 mg Desvenlafaxine Comparator (Pristiq®) Under Fasting Condition After Single Dose Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03357796
- Acronym / sponsor ID
- LY03005/CT-USA-104
- 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
- 20 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 30 Nov 2017 (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
Twenty (20) 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 |
|---|---|---|
| Group A: LY03005 cross-over to Pristiq® | Experimental | Drug: LY03005, Drug: PristiqSubjects in Group A will receive an 80 mg oral dose of LY03005 and the subjects will stay in the CRU for 4 days (Period 1). 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®) comparator followed by a 4-day stay in the CRU (Period 2). |
| Group B: Pristiq® cross-over to LY03005 | Experimental | Drug: LY03005, Drug: PristiqSubjects in Group B will receive a 50 mg oral dose of desvenlafaxine (Pristiq®) comparator and the subjects will stay in the CRU for 4 days (Period 1). After a washout period of up to 4 days, the subjects will be switched and will receive an 80 mg oral dose of LY03005 followed by a 4-day stay in the CRU (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 study procedures;
- Male and female subjects between the ages of 18 and 50 years;
- Considered healthy as assessed by the principal 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 in more than 6 months before Screening based on subject report;
- Body mass index (BMI) of 19 to 28 kg/m2 inclusive and body weight not less than 50 kg;
Key exclusion criteria (17 listed)
- Clinically significant past medical history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, ophthalmological, or drug hypersensitivity or any condition that in the judgement of the investigator will affect the study results or the subject's safety;
- History of suicide attempt in the past 12 months and/or seen by the investigators 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;
- Clinically relevant illness within 1 month prior to the Screening Visit or at Screening Visit that may interfere with the conduct of this study;
- Subjects with a mean systolic blood pressure >140 mmHg or a mean diastolic blood pressure of >90 mmHg at Screening after 3 measurements (after 5 minutes of rest in a sitting 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 |
|---|---|---|
| LY0300580 mg, oral tablets, single dose | Drug | Group A: LY03005 cross-over to Pristiq®, Group B: Pristiq® cross-over to LY03005 |
| PristiqAlso: Desvenlafaxine50 mg, oral tablets, single dose | Drug | Group A: LY03005 cross-over to Pristiq®, Group B: Pristiq® cross-over to LY03005 |
Primary outcome
Area under the concentration-time curve (AUC) Assessment
Time frame: PK Samples drawn at 0, 1,2,3,4, 6,8,10,12,24,32,48 and 72 hours after dosing in both Period 1 and Period 2.
Area under the concentration-time curve (AUC) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005 and ODV from Pristiq will be determined.
Maximum concentration (Cmax) Assessment
Time frame: PK Samples drawn at 0, 1,2,3,4, 6,8,10,12,24,32,48 and 72 hours after dosing in both Period 1 and Period 2.
Maximum concentration (Cmax) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005 and ODV from Pristiq will be determined.
1 secondary outcome
Adverse Events Assessment
Time frame: up to 35 days
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 4 Jan 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.
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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 7 inclusion and 17 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 4 Jan 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?
Area under the concentration-time curve (AUC) Assessment (time frame: PK Samples drawn at 0, 1,2,3,4, 6,8,10,12,24,32,48 and 72 hours after dosing in both Period 1 and Period 2.). 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 4 Jan 2018.