Major Depressive DisorderPhase 1LY03005SADNCT02055300
Safety, Tolerability and Pharmacokinetics Study of LY03005
A Phase 1 study testing LY03005, Meal and Pristiq in people with Major Depressive Disorder, run by Luye Pharma Group Ltd. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- LY03005, Meal and Pristiq
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are capable of giving informed consent and complying with study procedures;
- Are between the ages of 18 and 45 years, inclusive;
- Female subjects have a negative pregnancy test result prior to enrollment, and meet the following criteria defined as:
- If child-bearing potential, agree to avoid pregnancy during the study and one month after the end of the study by using at least one effective contraceptive method(s), such as an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives used for at least one month prior to screening, injectable progesterone, or progesterone sub-dermal implants.
- Surgically sterile for at least 3 months prior to screening by one of the following means:
- Bilateral tubal ligation
Show all 15Show fewer
- Salpingectomy (with or without oophorectomy)
- Surgical hysterectomy
- Bilateral oophorectomy (with or without hysterectomy)
- Postmenopausal, defined as one of the following:
- Last menstrual period greater than 12 months prior to screening
- 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;
- Body mass index (BMI) of 19 to 32 kg/m2 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.
Who cannot join
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
- Subjects with a mean systolic blood pressure of three measurements >130 mmHG, or a mean diastolic blood pressure of three measurements >90 mmHG at screening.
- History or presence of malignancy other than adequately treated basal cell skin cancer
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
- A history of seizure. However, a history of febrile seizure is allowed;
- Positive pregnancy test result, or plan to be pregnant if female;
Show all 18Show fewer
- A hospital admission or major surgery within 30 days prior to screening;
- Participation in any other investigational drug trial within 30 days from the last dosing of other trials 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;
- 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);
- A history of intolerance or hypersensitivity to venlafaxine or desvenlafaxine or any excipients;
- Patients with a history of suicide attempt in the past 6 months and/or seen by the investigator as having a significant history of risk of suicide or homicide;
- An unwillingness of male participants to use appropriate contraceptive measures if engaging in sex intercourse with a female partner of childbearing potential. Appropriate measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone sub-dermal implants, or a tubal ligation. Sexual intercourse with pregnant or lactating women is prohibited.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03005
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.
- Conditions
- Major Depressive Disorder
- Being tested
- LY03005, Placebo, Meal, 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
PlaceboDrug
MealOther
PristiqDrug
| Study group | Role | What they receive |
|---|---|---|
| LY03005 - 20 | Experimental | LY03005 Dose Strength 20mg Receives: Drug: LY03005; Drug: Placebo |
| LY03005 - 40 | Experimental | LY03005 Dose Strength 40mg Receives: Drug: LY03005; Drug: Placebo |
| LY03005- 80 | Experimental | LY03005 Dose Strength 80mg Receives: Drug: LY03005; Drug: Placebo |
| LY03005 - 120 | Experimental | LY03005 Dose Strength 120mg Receives: Drug: LY03005; Drug: Placebo |
| LY03005 - 160 | Experimental | LY03005 Dose Strength 160 mg Receives: Drug: LY03005; Drug: Placebo |
| LY03005 - 200 | Experimental | LY03005 Dose Strength 200mg Receives: Drug: LY03005; Drug: Placebo |
| LY03005 - 120 - Fed | Experimental | LY03005 120mg under Fed Conditions Receives: Drug: LY03005; Other: Meal |
| Pristiq | Active comparator | Pristiq - 50mg Receives: Drug: Pristiq |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 11 Days
Secondary outcomes (1)
PK parameters of: Cmax,
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 posted5 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionAug 2014
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Li, Study chair, Luye Pharma Group Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055300
- Sponsor's protocol ID
- LY03005
- Acronym
- LY03005SAD
- Status last verified
- Nov 2014
- First submitted
- 31 Jan 2014
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03005
- ClinicalTrials.gov ID
- NCT02055300
- Acronym / sponsor ID
- LY03005SAD / LY03005
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Feb 2014 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| LY03005 - 20 | Experimental | Drug: LY03005, Drug: PlaceboLY03005 Dose Strength 20mg |
| LY03005 - 40 | Experimental | Drug: LY03005, Drug: PlaceboLY03005 Dose Strength 40mg |
| LY03005- 80 | Experimental | Drug: LY03005, Drug: PlaceboLY03005 Dose Strength 80mg |
| LY03005 - 120 | Experimental | Drug: LY03005, Drug: PlaceboLY03005 Dose Strength 120mg |
| LY03005 - 160 | Experimental | Drug: LY03005, Drug: PlaceboLY03005 Dose Strength 160 mg |
| LY03005 - 200 | Experimental | Drug: LY03005, Drug: PlaceboLY03005 Dose Strength 200mg |
| LY03005 - 120 - Fed | Experimental | Drug: LY03005, Other: MealLY03005 120mg under Fed Conditions |
| Pristiq | Active comparator | Drug: PristiqPristiq - 50mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Are capable of giving informed consent and complying with study procedures;
- Are between the ages of 18 and 45 years, inclusive;
- Female subjects have a negative pregnancy test result prior to enrollment, and meet the following criteria defined as:
- 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;
Key exclusion criteria (18 listed)
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
- Subjects with a mean systolic blood pressure of three measurements >130 mmHG, or a mean diastolic blood pressure of three measurements >90 mmHG at screening.
- History or presence of malignancy other than adequately treated basal cell skin cancer
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
- A history of seizure. However, a history of febrile seizure is allowed;
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 |
|---|---|---|
| LY03005 | Drug | LY03005 - 120, LY03005 - 120 - Fed, LY03005 - 160, LY03005 - 20, LY03005 - 200, LY03005 - 40, LY03005- 80 |
| Placebo | Drug | LY03005 - 120, LY03005 - 160, LY03005 - 20, LY03005 - 200, LY03005 - 40, LY03005- 80, Placebo |
| Meal | Other | LY03005 - 120 - Fed |
| Pristiq | Drug | Pristiq |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 11 Days
1 secondary outcome
PK parameters of: Cmax,
Time frame: 4 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 10 Nov 2014.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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 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, Meal 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 15 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 10 Nov 2014. 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. Some participants in this study may receive a placebo. 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 11 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 10 Nov 2014.