HealthyPhase 1NCT03792139
An Interaction Study of LY3200882 in Healthy Participants
A Phase 1 study testing LY3200882 and Itraconazole 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 evaluate the effect of itraconazole on the amount of LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety and tolerability of LY3200882 when given with itraconazole will be evaluated. 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?
- LY3200882 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 23 Feb 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
- Healthy males or postmenopausal females, as determined by medical history and physical examination
Who cannot join
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing and during the study (with the exception of vitamins and occasional acetaminophen or ibuprofen, which will be permitted at the discretion of the investigator). Drugs that are known substrates, inducers, or inhibitors of CYP3A4 are specifically excluded within 30 days of dosing and throughout the study
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: Effects of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of LY3200882 in Healthy Subjects
The main purpose of this study is to evaluate the effect of itraconazole on the amount of LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety and tolerability of LY3200882 when given with itraconazole will be evaluated. The study is expected to last up to 19 days from the first dose to follow-up (inclusive). Screening will occur up to 28 days prior to enrollment.
- Conditions
- Healthy
- Being tested
- LY3200882, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3200882Drug
Administered orally.
ItraconazoleDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3200882 | Experimental | LY3200882 administered orally. Receives: Drug: LY3200882 |
| Itraconazole + LY3200882 | Experimental | Itraconazole + LY3200882 administered orally. Receives: Drug: LY3200882; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882
PK: Cmax of LY3200882
Measured: Baseline through 72 hours post-dose
PK: Area Under the Concentration Curve (AUC) of LY3200882
PK: AUC of LY3200882
Measured: Baseline through 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start8 Jan 2019
- Primary completion23 Feb 2019
- Study completion23 Feb 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT03792139
- Sponsor's protocol ID
- 16616
- Other IDs
- I8X-MC-JECC
- Status last verified
- Mar 2019
- First submitted
- 2 Jan 2019
- Last updated
- 8 Mar 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 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of LY3200882 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03792139
- Acronym / sponsor ID
- 16616
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 23 Feb 2019 (actual)
- Study completion
- 23 Feb 2019 (actual)
- First posted
- 3 Jan 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 evaluate the effect of itraconazole on the amount of LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety and tolerability of LY3200882 when given with itraconazole will be evaluated. The study is expected to last up to 19 days from the first dose to follow-up (inclusive). Screening will occur up to 28 days prior to enrollment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3200882 | Experimental | Drug: LY3200882LY3200882 administered orally. |
| Itraconazole + LY3200882 | Experimental | Drug: LY3200882, Drug: ItraconazoleItraconazole + LY3200882 administered orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy males or postmenopausal females, as determined by medical history and physical examination
Key exclusion criteria (2 listed)
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing and during the study (with the exception of vitamins and occasional acetaminophen or ibuprofen, which will be permitted at the discretion of the investigator). Drugs that are known substrates, inducers, or inhibitors of CYP3A4 are specifically excluded within 30 days of dosing and throughout the study
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 |
|---|---|---|
| LY3200882Administered orally. | Drug | Itraconazole + LY3200882, LY3200882 |
| ItraconazoleAdministered orally. | Drug | Itraconazole + LY3200882 |
Primary outcome
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882
Time frame: Baseline through 72 hours post-dose
PK: Cmax of LY3200882
PK: Area Under the Concentration Curve (AUC) of LY3200882
Time frame: Baseline through 72 hours post-dose
PK: AUC of LY3200882
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 8 Mar 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
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 LY3200882 and Itraconazole 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 1 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 8 Mar 2019. 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?
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882 (time frame: Baseline through 72 hours post-dose). 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 8 Mar 2019.