HealthyPhase 1NCT03252015
A Study of Multiple Doses of Lasmiditan in Healthy Participants
A Phase 1 study testing Probe Drug Cocktail and Lasmiditan in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it. When drugs are taken together, one or all of the drugs used in combination may be affected. 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?
- Probe Drug Cocktail and Lasmiditan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 2 Jan 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 females, as determined by medical history and physical examination
- Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening
Who cannot join
- Have participated, within the last 30 days, in a clinical study involving an Investigational Product (IP)
- Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan
- Have clinically significant abnormality in the 12-lead ECG, including corrected QT interval (QTc) with Fridericia's correction (QTcF) greater than (>) 450 milliseconds (ms) for men or >470 ms for women or any abnormality that in the opinion of the investigator increases the risk of participating in the study (not limited to significant bradycardia or heart block)
- History of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression), have a recent history of a suicide attempt (30 days within screening visit and any time between screening visit and baseline); or are clinically judged by the investigator to be at risk for suicide
- History of hypoglycemia
- Known history of glucose-6-phosphate dehydrogenase deficiency
- Are taking a concomitant medication or a dietary substance that affects cytochrome P450 (CYP)1A2, CYP2C9, and/or CYP3A isotypes within 14 days of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Drug-Drug Interaction Study of Lasmiditan
The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it.
When drugs are taken together, one or all of the drugs used in combination may be affected. This study will also evaluate the concentrations in the blood of a probe drug cocktail taken alone and in combination with lasmiditan. Information about any side effects that may occur will also be collected.
Read more
The study has two parts. Participants will only enroll in one part. This study will last about 25 days for group 1 and 22 days for group 2, not including screening. Screening is required within 28 days prior to the start of the study.
This study is for research purposes only and is not intended to treat any medical condition.
- Conditions
- Healthy
- Being tested
- Probe Drug Cocktail, Lasmiditan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probe Drug CocktailDrug
Administered orally
LasmiditanDrug
Also called LY573144
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Probe Drug Cocktail (Cohort 1a) | Experimental | Probe Drug Cocktail administered orally on Day -3. Receives: Drug: Probe Drug Cocktail |
| 200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1) | Experimental | 200 mg lasmiditan administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7. Receives: Drug: Probe Drug Cocktail; Drug: Lasmiditan |
| Placebo+Probe Drug Cocktail (Cohort 1b) | Placebo comparator | Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7. Receives: Drug: Probe Drug Cocktail; Drug: Placebo |
| 400 mg Lasmiditan (Cohort 2a) | Experimental | 400 mg lasmiditan administered orally for 7 days. Receives: Drug: Lasmiditan |
| Placebo (Cohort 2b) | Experimental | Placebo administered orally for 7 days. Receives: Drug: Placebo |
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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.
Measured: Baseline through 14 days after last administration of study drug
Secondary outcomes (10)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1
PK: Cmax of lasmiditan
Measured: Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7
PK: Cmax of lasmiditan Day 7
Measured: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1
PK: AUCtau of lasmiditan
Measured: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7
PK AUCtau of lasmiditan
Measured: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score
BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort.
Measured: PreDose Day 7 and Day 21
Physician Withdrawal Checklist (PWC)Total Score
Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Measured: Day 7 and Day 21 at anytime
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1
Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.
Measured: Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7
Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.
Measured: Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam
PK: Cmax of midazolam.
Measured: Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose,
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7
PK of midazolam.
Measured: Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start15 Aug 2017
- Primary completion2 Jan 2018
- Study completion2 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 70 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
- NCT03252015
- Sponsor's protocol ID
- 16859
- Other IDs
- H8H-MC-LAHE
- Status last verified
- Mar 2018
- First submitted
- 15 Aug 2017
- Last updated
- 10 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Drug-Drug Interaction Study of Lasmiditan
- ClinicalTrials.gov ID
- NCT03252015
- Acronym / sponsor ID
- 16859
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Posted 10 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it.
When drugs are taken together, one or all of the drugs used in combination may be affected. This study will also evaluate the concentrations in the blood of a probe drug cocktail taken alone and in combination with lasmiditan. Information about any side effects that may occur will also be collected.
The study has two parts. Participants will only enroll in one part. This study will last about 25 days for group 1 and 22 days for group 2, not including screening. Screening is required within 28 days prior to the start of the study.
This study is for research purposes only and is not intended to treat any medical condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Probe Drug Cocktail (Cohort 1a) | Experimental | Drug: Probe Drug CocktailProbe Drug Cocktail administered orally on Day -3. |
| 200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1) | Experimental | Drug: Probe Drug Cocktail, Drug: Lasmiditan200 mg lasmiditan administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7. |
| Placebo+Probe Drug Cocktail (Cohort 1b) | Placebo comparator | Drug: Probe Drug Cocktail, Drug: PlaceboPlacebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7. |
| 400 mg Lasmiditan (Cohort 2a) | Experimental | Drug: Lasmiditan400 mg lasmiditan administered orally for 7 days. |
| Placebo (Cohort 2b) | Experimental | Drug: PlaceboPlacebo administered orally for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males or females, as determined by medical history and physical examination
- Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening
Key exclusion criteria (7 listed)
- Have participated, within the last 30 days, in a clinical study involving an Investigational Product (IP)
- Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan
- Have clinically significant abnormality in the 12-lead ECG, including corrected QT interval (QTc) with Fridericia's correction (QTcF) greater than (>) 450 milliseconds (ms) for men or >470 ms for women or any abnormality that in the opinion of the investigator increases the risk of participating in the study (not limited to significant bradycardia or heart block)
- History of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression), have a recent history of a suicide attempt (30 days within screening visit and any time between screening visit and baseline); or are clinically judged by the investigator to be at risk for suicide
- History of hypoglycemia
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 |
|---|---|---|
| Probe Drug CocktailAdministered orally | Drug | 200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1), Placebo+Probe Drug Cocktail (Cohort 1b), Probe Drug Cocktail (Cohort 1a) |
| LasmiditanAlso: LY573144Administered orally | Drug | 200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1), 400 mg Lasmiditan (Cohort 2a) |
| PlaceboAdministered orally | Drug | Placebo (Cohort 2b), Placebo+Probe Drug Cocktail (Cohort 1b) |
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: Baseline through 14 days after last administration of 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. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.
10 secondary outcomes
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1
Time frame: Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7
Time frame: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1
Time frame: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7
Time frame: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score
Time frame: PreDose Day 7 and Day 21
Physician Withdrawal Checklist (PWC)Total Score
Time frame: Day 7 and Day 21 at anytime
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1
Time frame: Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7
Time frame: Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam
Time frame: Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose,
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7
Time frame: Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Probe Drug Cocktail and Lasmiditan 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 7 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 10 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. 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?
Yes. Results are posted in the registry (first posted 10 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Baseline through 14 days after last 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 10 Jan 2020.