HealthyPhase 1NCT03579940

A Study of Lasmiditan in Healthy Japanese and Caucasian Participants

A Phase 1 study testing Lasmiditan in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in healthy Japanese and Caucasian participants. The study will also investigate how much lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan when given to Japanese and Caucasians. Read more about this study

Who is it for?: Ages 20 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lasmiditan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 27 Jun 2018to 9 Aug 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 20 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Are overtly healthy Japanese (first generation) or Caucasian males or females, as determined by medical history and physical examination
Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Who cannot join

Have known allergies to lasmiditan, related compounds or any components of the formulation of lasmiditan
Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan
Have an abnormal supine blood pressure at screening.
Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or a risk of falls, as judged to be clinically significant by the investigator, or have orthostatic decreases in supine blood pressure of >20 millimeters of mercury (mmHg), or have orthostatic decreases in diastolic blood pressure of >10 mmHg at screening.
Are women who are pregnant, lactating, or have a positive pregnancy test at screening or admission to the clinical research unit (CRU)
Have donated blood of more than 500 milliliters (mL) within 1 month prior to screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Japanese and Caucasian Subjects

Conditions: Healthy
Being tested: Lasmiditan, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LasmiditanDrug
Also called LY573144
Administered orally.
PlaceboDrug
Administered orally.

Study groups in NCT03579940
Study group	Role	What they receive
Lasmiditan - Japanese	Experimental	Single (50 milligram (mg), 100 mg, 200 mg, 400 mg) and repeated (2 × 200 mg) doses of Lasmiditan administered orally in up to three of three study periods. Receives: Drug: Lasmiditan
Placebo - Japanese	Placebo comparator	Single and repeated (2 X placebo) doses of Placebo administered orally in up to one of three study periods. Receives: Drug: Placebo
Lasmiditan - Caucasian	Experimental	Single (50 mg, 100 mg, 200 mg) dose of Lasmiditan administered orally in up to three of three study periods. Receives: Drug: Lasmiditan
Placebo - Caucasian	Placebo comparator	Single dose of Placebo administered orally in up to one of three study periods. 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
The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
Measured: Baseline up to Day 20

Secondary outcomes (2)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period
PK: AUC(0-∞) of Lasmiditan in Each Period was evaluated.
Measured: Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose
PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period
PK: Cmax of Lasmiditan in Each Period was evaluated.
Measured: Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 20189 Aug 2018

First posted9 Jul 2018
Study start27 Jun 2018
Primary completion9 Aug 2018
Study completion9 Aug 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03579940
Sponsor's protocol ID: 17010
Other IDs: H8H-JE-LAIE
Status last verified: Aug 2018
First submitted: 25 Jun 2018
Last updated: 29 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Japanese and Caucasian Subjects
ClinicalTrials.gov ID: NCT03579940
Acronym / sponsor ID: 17010
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 27 Jun 2018 (actual)
Primary completion: 9 Aug 2018 (actual)
Study completion: 9 Aug 2018 (actual)
First posted: 9 Jul 2018 (actual)
Results: Posted 29 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Lasmiditan - Japanese	Experimental	Drug: LasmiditanSingle (50 milligram (mg), 100 mg, 200 mg, 400 mg) and repeated (2 × 200 mg) doses of Lasmiditan administered orally in up to three of three study periods.
Placebo - Japanese	Placebo comparator	Drug: PlaceboSingle and repeated (2 X placebo) doses of Placebo administered orally in up to one of three study periods.
Lasmiditan - Caucasian	Experimental	Drug: LasmiditanSingle (50 mg, 100 mg, 200 mg) dose of Lasmiditan administered orally in up to three of three study periods.
Placebo - Caucasian	Placebo comparator	Drug: PlaceboSingle dose of Placebo administered orally in up to one of three study periods.

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Are overtly healthy Japanese (first generation) or Caucasian males or females, as determined by medical history and physical examination
Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Key exclusion criteria (6 listed)

Have known allergies to lasmiditan, related compounds or any components of the formulation of lasmiditan
Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan
Have an abnormal supine blood pressure at screening.
Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or a risk of falls, as judged to be clinically significant by the investigator, or have orthostatic decreases in supine blood pressure of >20 millimeters of mercury (mmHg), or have orthostatic decreases in diastolic blood pressure of >10 mmHg at screening.
Are women who are pregnant, lactating, or have a positive pregnancy test at screening or admission to the clinical research unit (CRU)

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
LasmiditanAlso: LY573144Administered orally.	Drug	Lasmiditan - Caucasian, Lasmiditan - Japanese
PlaceboAdministered orally.	Drug	Placebo - Caucasian, Placebo - Japanese

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 up to Day 20
The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.

2 secondary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period
Time frame: Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose
PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period
Time frame: Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose

Results and safety

Results posted to the registry on 29 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Sequence 1: Japanese	3	3
Cohort 1: Sequence 2: Japanese	2	2
Cohort 1: Sequence 3: Japanese	2	2
Cohort 2: Sequence 1: Japanese	2	2
Cohort 2: Sequence 2: Japanese	2	2
Cohort 2: Sequence 3: Japanese	2	2
Cohort 2: Sequence 4: Japanese	3	3
Cohort 3: Sequence 1: Caucasian	3	3
Cohort 3: Sequence 2: Caucasian	3	3
Cohort 3: Sequence 3: Caucasian	2	2
Cohort 3: Sequence 4: Caucasian	3	3

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 up to Day 20. Count of participants. Unit: Participants

Measure	Placebo: Japanese n = 10	Placebo: Caucasian n = 8	2 x Placebo: Japanese n = 2	50 mg Lasmiditan: Japanese n = 6	50 mg Lasmiditan: Caucasian n = 8	100 mg Lasmiditan: Japanese n = 7	100 mg Lasmiditan: Caucasian n = 8	200 mg Lasmiditan: Japanese n = 8	200 mg Lasmiditan: Caucasian n = 9	400 mg Lasmiditan: Japanese n = 7	2 X 200 mg Lasmiditan: Japanese n = 7
Value	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All enrolled participants who received at least one dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 20 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo: Japanese	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Placebo: Caucasian	0 of 8 (0%)	0 of 8 (0%)	0 of 8
2 x Placebo: Japanese	0 of 2 (0%)	0 of 2 (0%)	0 of 2
50 mg Lasmiditan: Japanese	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
50 mg Lasmiditan: Caucasian	0 of 8 (0%)	4 of 8 (50%)	0 of 8
100 mg Lasmiditan: Japanese	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7
100 mg Lasmiditan: Caucasian	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
200 mg Lasmiditan: Japanese	0 of 8 (0%)	6 of 8 (75%)	0 of 8
200 mg Lasmiditan: Caucasian	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
400 mg Lasmiditan: Japanese	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
2 x 200 mg Lasmiditan: Japanese	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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 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 6 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 29 Nov 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. 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 29 Nov 2019). 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 up to Day 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579940.

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 29 Nov 2019.