HealthyPhase 1NCT03942029
A Drug Interaction Study of LY3154207 in Healthy Participants
A Phase 1 study testing LY3154207 Capsule, LY3154207 Tablet and Fluconazole Tablet in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to learn more about the safety and side effects of LY3154207 and fluconazole (anti-fungal medication), when taken together by healthy participants. The study will last from nine to 11 weeks for each participant. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3154207 Capsule, LY3154207 Tablet and Fluconazole Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2019to 28 Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a body mass index (BMI) of 18 to 35 kilogram per meter square (kg/m²)
- Have clinical laboratory test results within acceptable range for the population
Who cannot join
- Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
- Intend to use over-the-counter or prescription medication (with exception of hormonal contraceptives and acetaminophen), including herbal preparations containing St. John's wort, kava, garlic, ginger, ginkgo biloba, or guarana, within 14 days prior to Check-in and during the study
- Use of any drugs or substances that are known inducers and/or inhibitors of cytochrome P450 (CYP) 3A within 14 days prior to the administration of study drug and during the study
- Have evidence of active renal disease (eg, diabetic renal disease, polycystic kidney disease) or an estimated creatinine clearance of < 80 milliliters per minute (mL/minute), calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
About this study
Official title: Safety and Tolerability of LY3154207 in Combination With a CYP3A4 Inhibitor and Assessment of Pharmacokinetics of LY3154207 After Administration of Capsule and Tablet Formulations in Healthy Subjects
The main purpose of this study is to learn more about the safety and side effects of LY3154207 and fluconazole (anti-fungal medication), when taken together by healthy participants. The study will last from nine to 11 weeks for each participant.
- Conditions
- Healthy
- Being tested
- LY3154207 Capsule, LY3154207 Tablet, Placebo, Fluconazole Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3154207 CapsuleDrug
Administered orally as capsule
LY3154207 TabletDrug
Administered orally as tablet
PlaceboDrug
Also called Placebo Tablet
Administered orally as tablet
Fluconazole TabletDrug
Administered orally as tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Part A - LY3154207 Capsule | Experimental | LY3154207 capsule (reference) administered orally, once. Receives: Drug: LY3154207 Capsule |
| Cohort 1 Part A - LY3154207 Tablet | Experimental | LY3154207 tablet (test) administered orally, once. Receives: Drug: LY3154207 Tablet |
| Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole | Experimental | LY3154207 (dose 1) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days. Receives: Drug: LY3154207 Tablet; Drug: Fluconazole Tablet |
| Cohort 1 Part B - Placebo + Fluconazole | Experimental | Placebo administered alone, orally, once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days. Receives: Drug: Placebo; Drug: Fluconazole Tablet |
| Cohort 2 - LY3154207 (Dose 2) + Fluconazole | Experimental | LY3154207 (dose 2) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days. Receives: Drug: LY3154207 Tablet; Drug: Fluconazole Tablet |
| Cohort 2 - Placebo + Fluconazole | Experimental | Placebo administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days. Receives: Drug: Placebo; Drug: Fluconazole Tablet |
| Cohort 3 - LY3154207 + Fluconazole | Experimental | LY3154207 (dose 2) administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days. Receives: Drug: LY3154207 Tablet; Drug: Fluconazole Tablet |
| Cohort 3 - Placebo + Fluconazole | Experimental | Placebo administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days. Receives: Drug: Placebo; Drug: Fluconazole Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline up to 11 weeks
Secondary outcomes (5)
Change from Baseline in Blood Pressure (BP)
BP measured by ambulatory blood pressure monitoring (ABPM)
Measured: Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole
Change from Baseline in Pulse Rate (PR)
PR measured by ABPM
Measured: Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154207
PK: Cmax of LY3154207
Measured: Baseline up to 48 hours postdose
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time T, where T is the Last Sample with a Measurable Concentration (AUC[0-tlast]) of LY3154207
PK: AUC(0-tlast) of LY3154207
Measured: Baseline up to 48 hours postdose
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3154207
PK: AUC(0-inf) of LY3154207
Measured: Baseline up to 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start21 Jun 2019
- Primary completion28 Dec 2019
- Study completion28 Dec 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT03942029
- Sponsor's protocol ID
- 16304
- Other IDs
- I7S-MC-HBEF
- Status last verified
- 15 Jan 2020
- First submitted
- 7 May 2019
- Last updated
- 18 Jan 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of LY3154207 in Combination With a CYP3A4 Inhibitor and Assessment of Pharmacokinetics of LY3154207 After Administration of Capsule and Tablet Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03942029
- Acronym / sponsor ID
- 16304
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 8 May 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 purpose of this study is to learn more about the safety and side effects of LY3154207 and fluconazole (anti-fungal medication), when taken together by healthy participants. The study will last from nine to 11 weeks for each participant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Part A - LY3154207 Capsule | Experimental | Drug: LY3154207 CapsuleLY3154207 capsule (reference) administered orally, once. |
| Cohort 1 Part A - LY3154207 Tablet | Experimental | Drug: LY3154207 TabletLY3154207 tablet (test) administered orally, once. |
| Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole | Experimental | Drug: LY3154207 Tablet, Drug: Fluconazole TabletLY3154207 (dose 1) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days. |
| Cohort 1 Part B - Placebo + Fluconazole | Experimental | Drug: Placebo, Drug: Fluconazole TabletPlacebo administered alone, orally, once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days. |
| Cohort 2 - LY3154207 (Dose 2) + Fluconazole | Experimental | Drug: LY3154207 Tablet, Drug: Fluconazole TabletLY3154207 (dose 2) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days. |
| Cohort 2 - Placebo + Fluconazole | Experimental | Drug: Placebo, Drug: Fluconazole TabletPlacebo administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days. |
| Cohort 3 - LY3154207 + Fluconazole | Experimental | Drug: LY3154207 Tablet, Drug: Fluconazole TabletLY3154207 (dose 2) administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days. |
| Cohort 3 - Placebo + Fluconazole | Experimental | Drug: Placebo, Drug: Fluconazole TabletPlacebo administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a body mass index (BMI) of 18 to 35 kilogram per meter square (kg/m²)
- Have clinical laboratory test results within acceptable range for the population
Key exclusion criteria (4 listed)
- Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
- Intend to use over-the-counter or prescription medication (with exception of hormonal contraceptives and acetaminophen), including herbal preparations containing St. John's wort, kava, garlic, ginger, ginkgo biloba, or guarana, within 14 days prior to Check-in and during the study
- Use of any drugs or substances that are known inducers and/or inhibitors of cytochrome P450 (CYP) 3A within 14 days prior to the administration of study drug and during the study
- Have evidence of active renal disease (eg, diabetic renal disease, polycystic kidney disease) or an estimated creatinine clearance of < 80 milliliters per minute (mL/minute), calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
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 |
|---|---|---|
| LY3154207 CapsuleAdministered orally as capsule | Drug | Cohort 1 Part A - LY3154207 Capsule |
| LY3154207 TabletAdministered orally as tablet | Drug | Cohort 1 Part A - LY3154207 Tablet, Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole, Cohort 2 - LY3154207 (Dose 2) + Fluconazole, Cohort 3 - LY3154207 + Fluconazole |
| PlaceboAlso: Placebo TabletAdministered orally as tablet | Drug | Cohort 1 Part B - Placebo + Fluconazole, Cohort 2 - Placebo + Fluconazole, Cohort 3 - Placebo + Fluconazole |
| Fluconazole TabletAdministered orally as tablet | Drug | Cohort 1 Part B - Placebo + Fluconazole, Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole, Cohort 2 - LY3154207 (Dose 2) + Fluconazole, Cohort 2 - Placebo + Fluconazole, Cohort 3 - LY3154207 + Fluconazole, Cohort 3 - Placebo + Fluconazole |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Time frame: Baseline up to 11 weeks
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
5 secondary outcomes
Change from Baseline in Blood Pressure (BP)
Time frame: Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole
Change from Baseline in Pulse Rate (PR)
Time frame: Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154207
Time frame: Baseline up to 48 hours postdose
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time T, where T is the Last Sample with a Measurable Concentration (AUC[0-tlast]) of LY3154207
Time frame: Baseline up to 48 hours postdose
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3154207
Time frame: Baseline up to 48 hours postdose
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 18 Jan 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 LY3154207 Capsule, LY3154207 Tablet and Fluconazole Tablet in people with Healthy, run by Eli Lilly and Company 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 2 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 18 Jan 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 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?
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug (time frame: Baseline up to 11 weeks). 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 18 Jan 2020.