Major DepressionPhase 1NCT02988024
Pilot BA Study of New LY03005 vs Pristiq
A Phase 1 study testing LY03005 and Pristiq in people with Major Depression, run by Luye Pharma Group Ltd. at 1 site in United States.
Trial summary
The objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005 oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under fasting conditions 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 Depression
- What is being tested?
- LY03005 and Pristiq
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2016to 28 Dec 2016
- 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
- Are capable of giving informed consent and complying with study procedures;
- Male and female subjects between the ages of 18 and 50 years;
- Considered healthy 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 30 kg/m 2 inclusive and body weight not less than 50 kg;
- Willing and able to adhere to study restrictions and to be confined at the clinical research center.
- All female subjects no matter of age must have a negative pregnancy test result at screening. In addition, female subjects must meet one of the following three 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 oral, injected, vaginal or patch contraceptive, IUD (Intrauterine device)(copper intrauterine device), 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 one month after the end of the study.
Who cannot join
- Clinically significant past history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, ophthalmological, or drug hypersensitivity;
- History of suicide attempt in the past 12 months and/or seen by the investigators having a significant history of risk of suicide or homicide;
- History or presence of malignancy other than adequately treated basal cell skin cancer;
- Clinically relevant illness within one 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 of three measurements >140 mmHg, or a mean diastolic blood pressure of three measurements >90 mmHg at screening;
- 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, drugs of abuse;
- Tobacco use within 6 months prior to screening based on subject report;
- Subjects with hypersensitivity to PRISTIQ or medicines containing desvenlafaxine or its precursor venlafaxine;
- Subjects who have participated in a previous clinical study of either LY03005 or PRISTIQ or medicines containing desvenlafaxine or its precursor, venlafaxine within 30 days prior to screening;
- An unwillingness or inability to comply with food and beverage restrictions during study participation;
- Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (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 herbal (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, Single-Dose Study to Assess the Relative Bioavailability of LY03005 Oral Tablets Versus Pristiq Oral Tablets Under Fasting Conditions in Healthy Subjects
The objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005 oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under fasting conditions 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 LY03005 group or Pristiq group at a 1:1 ratio at one site in the USA.
- Conditions
- Major Depression
- Being tested
- LY03005, Pristiq
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03005Drug
LY03005
PristiqDrug
Also called Desvenlafaxine
| Study group | Role | What they receive |
|---|---|---|
| LY03005 | Experimental | LY03005 80 mg Receives: Drug: LY03005 |
| Pristiq | Active comparator | Pristiq 50 mg Receives: Drug: Pristiq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) for the Pharmacokinetics (PK) of LY03005
PK Samples drawn at 0 (within 30 minutes prior to dosing), 1,2,3,4 (+/- 5 min), 6,8,10,12,23,32,48 and 72 hours (+/- 15 min) after dosing.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start7 Dec 2016
- Primary completion28 Dec 2016
- Study completion28 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies 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
- Parallel groups
- 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
- Simon Li, M.D., Study chair, Luye Pharma Group Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988024
- Sponsor's protocol ID
- LY03005/CT-USA-103
- Status last verified
- Mar 2017
- First submitted
- 2 Dec 2016
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single-Dose Study to Assess the Relative Bioavailability of LY03005 Oral Tablets Versus Pristiq Oral Tablets Under Fasting Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02988024
- Acronym / sponsor ID
- LY03005/CT-USA-103
- Conditions
- Major Depression
- 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
- 7 Dec 2016 (actual)
- Primary completion
- 28 Dec 2016 (actual)
- Study completion
- 28 Dec 2016 (actual)
- First posted
- 9 Dec 2016 (estimated)
- 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 objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005 oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under fasting conditions in healthy subjects between 18 and 50 years of age.
Detailed description
Twenty (20) eligible subjects will be enrolled and assigned to either LY03005 group or Pristiq group at a 1:1 ratio at one site in the USA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY03005 | Experimental | Drug: LY03005LY03005 80 mg |
| Pristiq | Active comparator | Drug: PristiqPristiq 50 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Are capable of giving informed consent and complying with study procedures;
- Male and female subjects between the ages of 18 and 50 years;
- Considered healthy 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 30 kg/m 2 inclusive and body weight not less than 50 kg;
Key exclusion criteria (18 listed)
- Clinically significant past history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, ophthalmological, or drug hypersensitivity;
- History of suicide attempt in the past 12 months and/or seen by the investigators having a significant history of risk of suicide or homicide;
- History or presence of malignancy other than adequately treated basal cell skin cancer;
- Clinically relevant illness within one 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 of three measurements >140 mmHg, or a mean diastolic blood pressure of three measurements >90 mmHg at screening;
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 |
|---|---|---|
| LY03005LY03005 | Drug | LY03005 |
| PristiqAlso: Desvenlafaxine | Drug | Pristiq |
Primary outcome
Area under curve (AUC) for the Pharmacokinetics (PK) of LY03005
Time frame: 4 days
PK Samples drawn at 0 (within 30 minutes prior to dosing), 1,2,3,4 (+/- 5 min), 6,8,10,12,23,32,48 and 72 hours (+/- 15 min) after dosing.
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 20 Mar 2017.
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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.
Simon Li, M.D. 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 Depression, 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 18 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 20 Mar 2017. 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 curve (AUC) for the Pharmacokinetics (PK) of LY03005 (time frame: 4 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 20 Mar 2017.