HealthyPhase 1NCT04047940
A Study of LY900020 in Healthy Chinese Participants
A Phase 1 study testing LY900020, Metformin XR and Atorvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
This study will evaluate three new formulations of LY900020; a fixed dose, combination drug developed for people with type 2 diabetes mellitus. The study will be conducted in healthy participants to investigate the effect of different tablet formulations on the amount of LY900020 in the bloodstream. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY900020, Metformin XR and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Nov 2019to 18 Feb 2020
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
- Have a body mass index (BMI) of 18.5 to 35 kilogram per square meter (kg/m²), inclusive, at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
Who cannot join
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Had blood loss of more than 400 milliliters (mL) within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Relative Bioavailability Study of Three LY900020 Tablet Formulations in Healthy Chinese Subjects
This study will evaluate three new formulations of LY900020; a fixed dose, combination drug developed for people with type 2 diabetes mellitus. The study will be conducted in healthy participants to investigate the effect of different tablet formulations on the amount of LY900020 in the bloodstream. Side effects and tolerability will be documented. The study will last about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
- Conditions
- Healthy
- Being tested
- LY900020, Metformin XR, Atorvastatin, Valsartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY900020Drug
Administered orally
Metformin XRDrug
Administered orally
AtorvastatinDrug
Administered orally
ValsartanDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY900020 Formulation 1 | Experimental | LY900020 Formulation 1 administered orally Receives: Drug: LY900020 |
| LY900020 Formulation 2 | Experimental | LY900020 Formulation 2 administered orally Receives: Drug: LY900020 |
| LY900020 Formulation 3 | Experimental | LY900020 Formulation 3 administered orally Receives: Drug: LY900020 |
| Reference Drugs | Active comparator | Metformin XR, atorvastatin, and valsartan administered orally Receives: Drug: Metformin XR; Drug: Atorvastatin; Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY900020
PK: AUC of LY900020
Measured: Predose through 72 hours postdose on Day 4 in each study arm
PK: Maximum Observed Drug Concentration (Cmax) of LY900020
PK: Cmax of LY900020
Measured: Predose through 72 hours postdose on Day 4 in each study arm
Secondary outcomes (1)
PK: Time to Maximum Observed Drug Concentration (tmax) of LY900020
PK: Tmax of LY900020
Measured: Predose through 72 hours postdose on Day 4 in each study arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start29 Nov 2019
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047940
- Sponsor's protocol ID
- 16968
- Other IDs
- I9J-MC-DIPA
- Status last verified
- 1 Mar 2020
- First submitted
- 6 Aug 2019
- Last updated
- 3 Mar 2020
- 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 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of Three LY900020 Tablet Formulations in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04047940
- Acronym / sponsor ID
- 16968
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 7 Aug 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.
This study will evaluate three new formulations of LY900020; a fixed dose, combination drug developed for people with type 2 diabetes mellitus. The study will be conducted in healthy participants to investigate the effect of different tablet formulations on the amount of LY900020 in the bloodstream. Side effects and tolerability will be documented. The study will last about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY900020 Formulation 1 | Experimental | Drug: LY900020LY900020 Formulation 1 administered orally |
| LY900020 Formulation 2 | Experimental | Drug: LY900020LY900020 Formulation 2 administered orally |
| LY900020 Formulation 3 | Experimental | Drug: LY900020LY900020 Formulation 3 administered orally |
| Reference Drugs | Active comparator | Drug: Metformin XR, Drug: Atorvastatin, Drug: ValsartanMetformin XR, atorvastatin, and valsartan administered orally |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
- Have a body mass index (BMI) of 18.5 to 35 kilogram per square meter (kg/m²), inclusive, at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
Key exclusion criteria (4 listed)
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Had blood loss of more than 400 milliliters (mL) within the last 3 months
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 |
|---|---|---|
| LY900020Administered orally | Drug | LY900020 Formulation 1, LY900020 Formulation 2, LY900020 Formulation 3 |
| Metformin XRAdministered orally | Drug | Reference Drugs |
| AtorvastatinAdministered orally | Drug | Reference Drugs |
| ValsartanAdministered orally | Drug | Reference Drugs |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY900020
Time frame: Predose through 72 hours postdose on Day 4 in each study arm
PK: AUC of LY900020
PK: Maximum Observed Drug Concentration (Cmax) of LY900020
Time frame: Predose through 72 hours postdose on Day 4 in each study arm
PK: Cmax of LY900020
1 secondary outcome
PK: Time to Maximum Observed Drug Concentration (tmax) of LY900020
Time frame: Predose through 72 hours postdose on Day 4 in each study arm
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 3 Mar 2020.
- 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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
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 LY900020, Metformin XR and Atorvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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 3 inclusion and 4 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 3 Mar 2020. 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 Singapore. 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?
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY900020 (time frame: Predose through 72 hours postdose on Day 4 in each study arm). 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 3 Mar 2020.