Healthy ParticipantsPhase 1NCT02365571
A Study of LY3154207 in Healthy Participants
A Phase 1 study testing LY3154207 and Itraconazole in people with Healthy Participants, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on the body. There will be 3 parts to this study. Part A will test single increasing doses of LY3154207 and will last approximately 7 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 Participants
- What is being tested?
- LY3154207 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to May 2015
- 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
- Overtly healthy males or females, as determined by medical history and physical examination
- Female participants not of child-bearing potential
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Have given written informed consent
- Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m^2)
Who cannot join
- Part B only: Have medical or surgical conditions in which lumbar puncture is contraindicated
- Part C only: Have known allergy or contraindications to itraconazole
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Cytochrome P450 Interaction Study of LY3154207 in Healthy Subjects
This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on the body. There will be 3 parts to this study.
Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for each participant. Each participant will receive two doses of LY3154207, if part A is completed.
Read more
Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each participant. Part B includes collecting fluid from the spinal column to measure levels of LY3154207.
Part C will include a single dose of LY3154207 given alone and then a second dose given along with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for each participant.
Participants may only enroll in 1 of the 3 parts of the study.
- Conditions
- Healthy Participants
- Being tested
- LY3154207, Placebo, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3154207Drug
Administered orally
PlaceboDrug
Administered orally
ItraconazoleDrug
Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution
| Study group | Role | What they receive |
|---|---|---|
| LY3154207 (Part A) | Experimental | LY3154207 administered in ascending doses once orally in two of three study periods Receives: Drug: LY3154207 |
| Placebo (Part A) | Placebo comparator | Placebo matching LY3154207 administered once orally in one of three study periods. Receives: Drug: Placebo |
| LY3154207 (Part B) | Experimental | LY3154207 administered once orally. Receives: Drug: LY3154207 |
| Placebo (Part B) | Placebo comparator | Placebo matching LY3154207 administered once orally. Receives: Drug: Placebo |
| LY3154207 (Part C) | Experimental | LY3154207 administered once orally on Day 1 Receives: Drug: LY3154207 |
| LY3154207 + Itraconazole (Part C) | Experimental | Itraconazole administered orally (twice daily on Day 3 and then once daily to Day 12). LY3154207 co-administered once orally, on Day 9. Timing and duration of itraconazole dosing may be adjusted based on data from Part A. Receives: Drug: LY3154207; Drug: Itraconazole |
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 Administration
Measured: Up to 48 hours after administration of study drug
Secondary outcomes (6)
Pharmacokinetics (PK) Plasma Part A : Maximum Drug Concentration (Cmax) of LY3154207
Measured: Predose through 48 hours after administration of study drug
Pharmacokinetics (PK) Plasma Part A: Area Under the Concentration Curve (AUC) of LY3154207
Measured: Predose through 48 hours after administration of study drug
Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Area Under the Concentration Time Curve (AUC) of LY3154207
Measured: Predose through 48 hours after administration of study drug
Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Maximum Drug Concentration (Cmax) of LY3154207
Measured: Predose through 48 hours after administration of study drug
Pharmacokinetics (PK) Plasma Part C: Area Under the Concentration Time Curve (AUC) of LY3154207 when Co-administered with Itraconazole
Measured: Predose through 96 hours after administration of study drug
Pharmacokinetics (PK) Plasma Part C: Maximum Drug Concentration (Cmax) of LY3154207 when Co-administered with Itraconazole
Measured: Predose through 96 hours after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 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
- NCT02365571
- Sponsor's protocol ID
- 15510
- Other IDs
- I7S-EW-HBEA
- Status last verified
- Jun 2015
- First submitted
- 17 Feb 2015
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Cytochrome P450 Interaction Study of LY3154207 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02365571
- Acronym / sponsor ID
- 15510
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Feb 2015 (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.
This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on the body. There will be 3 parts to this study.
Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for each participant. Each participant will receive two doses of LY3154207, if part A is completed.
Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each participant. Part B includes collecting fluid from the spinal column to measure levels of LY3154207.
Part C will include a single dose of LY3154207 given alone and then a second dose given along with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for each participant.
Participants may only enroll in 1 of the 3 parts of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY3154207 (Part A) | Experimental | Drug: LY3154207LY3154207 administered in ascending doses once orally in two of three study periods |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo matching LY3154207 administered once orally in one of three study periods. |
| LY3154207 (Part B) | Experimental | Drug: LY3154207LY3154207 administered once orally. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPlacebo matching LY3154207 administered once orally. |
| LY3154207 (Part C) | Experimental | Drug: LY3154207LY3154207 administered once orally on Day 1 |
| LY3154207 + Itraconazole (Part C) | Experimental | Drug: LY3154207, Drug: ItraconazoleItraconazole administered orally (twice daily on Day 3 and then once daily to Day 12). LY3154207 co-administered once orally, on Day 9. Timing and duration of itraconazole dosing may be adjusted based on data from Part A. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Overtly healthy males or females, as determined by medical history and physical examination
- Female participants not of child-bearing potential
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Have given written informed consent
- Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m^2)
Key exclusion criteria (2 listed)
- Part B only: Have medical or surgical conditions in which lumbar puncture is contraindicated
- Part C only: Have known allergy or contraindications to itraconazole
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 |
|---|---|---|
| LY3154207Administered orally | Drug | LY3154207 (Part A), LY3154207 (Part B), LY3154207 (Part C), LY3154207 + Itraconazole (Part C) |
| PlaceboAdministered orally | Drug | Placebo (Part A), Placebo (Part B) |
| ItraconazoleAdministered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution | Drug | LY3154207 + Itraconazole (Part C) |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Up to 48 hours after administration of study drug
6 secondary outcomes
Pharmacokinetics (PK) Plasma Part A : Maximum Drug Concentration (Cmax) of LY3154207
Time frame: Predose through 48 hours after administration of study drug
Pharmacokinetics (PK) Plasma Part A: Area Under the Concentration Curve (AUC) of LY3154207
Time frame: Predose through 48 hours after administration of study drug
Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Area Under the Concentration Time Curve (AUC) of LY3154207
Time frame: Predose through 48 hours after administration of study drug
Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Maximum Drug Concentration (Cmax) of LY3154207
Time frame: Predose through 48 hours after administration of study drug
Pharmacokinetics (PK) Plasma Part C: Area Under the Concentration Time Curve (AUC) of LY3154207 when Co-administered with Itraconazole
Time frame: Predose through 96 hours after administration of study drug
Pharmacokinetics (PK) Plasma Part C: Maximum Drug Concentration (Cmax) of LY3154207 when Co-administered with Itraconazole
Time frame: Predose through 96 hours after administration of study drug
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 Jun 2015.
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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 and Itraconazole in people with Healthy Participants, 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 5 inclusion and 2 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 Jun 2015. 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 One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Up to 48 hours after administration of study drug). 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 Jun 2015.