HealthyPhase 1NCT03913260
A Study of Different Injectable Formulations of LY3375880 in Healthy Participants
A Phase 1 study testing LY3375880, Buffer Matrix (No LY3375880) and Autoinjector (AI) in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3375880, Buffer Matrix (No LY3375880) and Autoinjector (AI)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2019to 19 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are overtly healthy males or females, as determined by medical history and physical examination
- Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
- Females who are not of child-bearing potential
- Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Who cannot join
- Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
- Have participated or are currently enrolled in clinical trials with LY3375880
- Have infections or evidence of infections
- Are pregnant, lactating or breast feeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Covance
Dallas, Texas, 75247
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
About this study
Official title: A Safety, Tolerability, and Pharmacokinetic Study of Different Solution Formulations of LY3375880 Using Investigational Injection Devices in Healthy Subjects
The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.
- Conditions
- Healthy
- Being tested
- LY3375880, Buffer Matrix (No LY3375880), Autoinjector (AI), Manual Syringe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3375880Drug
Administered SC
Buffer Matrix (No LY3375880)Drug
Administered SC
Autoinjector (AI)Device
AI used to administer LY3375880 or Buffer Matrix
Manual SyringeDevice
Manual syringe used to inject LY3375880
| Study group | Role | What they receive |
|---|---|---|
| Part A: LY3375880 Formulation A | Experimental | LY3375880 Formulation A administered subcutaneously (SC). Receives: Drug: LY3375880; Device: Autoinjector (AI) |
| Part A: LY3375880 Formulation B | Experimental | LY3375880 Formulation B administered subcutaneously SC. Receives: Drug: LY3375880; Device: Autoinjector (AI) |
| Part A: LY3375880 Formulation C | Experimental | LY3375880 Formulation C administered SC. Receives: Drug: LY3375880; Device: Autoinjector (AI) |
| Part A: Positive Control | Placebo comparator | Positive Control (buffer matrix, only) administered SC. Receives: Drug: Buffer Matrix (No LY3375880); Device: Autoinjector (AI) |
| Part B: LY3375880 Test 1 | Experimental | LY3375880 Test 1 Formulation administered SC. Receives: Drug: LY3375880; Device: Manual Syringe |
| Part B: LY3375880 Test 2 | Experimental | LY3375880 Test 2 Formulation administered SC. Receives: Drug: LY3375880; Device: Manual Syringe |
| Part B: LY3375880 Test 3 | Experimental | LY3375880 Test 3 Formulation administered SC. Receives: Drug: LY3375880; Device: Manual Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain Score
The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).
Measured: Part A: Within 1-minute post injection
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880
PK: Cmax of LY3375880
Measured: Part B: Predose through Day 85
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880
PK: AUC of LY3375880
Measured: Part B: Predose through Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start1 May 2019
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
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
- Model description
- Part A is a crossover design. Part B is a parallel design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 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
- NCT03913260
- Sponsor's protocol ID
- 17212
- Other IDs
- I9N-MC-FCAC
- Status last verified
- Oct 2019
- First submitted
- 11 Apr 2019
- Last updated
- 11 Oct 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 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability, and Pharmacokinetic Study of Different Solution Formulations of LY3375880 Using Investigational Injection Devices in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03913260
- Acronym / sponsor ID
- 17212
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 12 Apr 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 main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Part A is a crossover design. Part B is a parallel design.
| Arm | Type | Receives |
|---|---|---|
| Part A: LY3375880 Formulation A | Experimental | Drug: LY3375880, Device: Autoinjector (AI)LY3375880 Formulation A administered subcutaneously (SC). |
| Part A: LY3375880 Formulation B | Experimental | Drug: LY3375880, Device: Autoinjector (AI)LY3375880 Formulation B administered subcutaneously SC. |
| Part A: LY3375880 Formulation C | Experimental | Drug: LY3375880, Device: Autoinjector (AI)LY3375880 Formulation C administered SC. |
| Part A: Positive Control | Placebo comparator | Drug: Buffer Matrix (No LY3375880), Device: Autoinjector (AI)Positive Control (buffer matrix, only) administered SC. |
| Part B: LY3375880 Test 1 | Experimental | Drug: LY3375880, Device: Manual SyringeLY3375880 Test 1 Formulation administered SC. |
| Part B: LY3375880 Test 2 | Experimental | Drug: LY3375880, Device: Manual SyringeLY3375880 Test 2 Formulation administered SC. |
| Part B: LY3375880 Test 3 | Experimental | Drug: LY3375880, Device: Manual SyringeLY3375880 Test 3 Formulation administered SC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are overtly healthy males or females, as determined by medical history and physical examination
- Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
- Females who are not of child-bearing potential
- Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Key exclusion criteria (4 listed)
- Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
- Have participated or are currently enrolled in clinical trials with LY3375880
- Have infections or evidence of infections
- Are pregnant, lactating or breast feeding
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 |
|---|---|---|
| LY3375880Administered SC | Drug | Part A: LY3375880 Formulation A, Part A: LY3375880 Formulation B, Part A: LY3375880 Formulation C, Part B: LY3375880 Test 1, Part B: LY3375880 Test 2, Part B: LY3375880 Test 3 |
| Buffer Matrix (No LY3375880)Administered SC | Drug | Part A: Positive Control |
| Autoinjector (AI)AI used to administer LY3375880 or Buffer Matrix | Device | Part A: LY3375880 Formulation A, Part A: LY3375880 Formulation B, Part A: LY3375880 Formulation C, Part A: Positive Control |
| Manual SyringeManual syringe used to inject LY3375880 | Device | Part B: LY3375880 Test 1, Part B: LY3375880 Test 2, Part B: LY3375880 Test 3 |
Primary outcome
Visual Analog Scale (VAS) Pain Score
Time frame: Part A: Within 1-minute post injection
The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880
Time frame: Part B: Predose through Day 85
PK: Cmax of LY3375880
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880
Time frame: Part B: Predose through Day 85
PK: AUC of LY3375880
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 11 Oct 2019.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3375880, Buffer Matrix (No LY3375880) and Autoinjector (AI) in people with Healthy, run by Eli Lilly and Company at 2 sites 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 5 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 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Visual Analog Scale (VAS) Pain Score (time frame: Part A: Within 1-minute post injection). The study lists 3 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 11 Oct 2019.