HealthyPhase 1NCT04081324

A Study of Lasmiditan in Healthy Chinese Participants

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

Completed

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

Trial summary

This is a study of lasmiditan in healthy Chinese participants. The purposes are: To evaluate the safety of lasmiditan To learn more about how the body processes lasmiditan The study will last up to 50 days for each participant. 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?: Lasmiditan
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 siteChina
Study dates: 13 Nov 2019to 15 Jun 2020
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

Are overtly healthy Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin) males or females, as determined by medical history and physical examination
Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter, inclusive
Are able and willing to give signed informed consent

Who cannot join

Have known allergies to lasmiditan, related compounds or any components of the formulation
Have an abnormal blood pressure and/or pulse rate as determined clinically significant by the investigator
Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
Have a history of central nervous system (CNS) conditions such as strokes, transient ischemic attack, significant head trauma, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increases the risk of participating in the study
Regularly use known drugs of abuse and/or show positive findings on drug screening

Trial locations and contacts

1 site in 1 country.

China1 site

HuaShan Hospital Affiliated To Fudan University
Shanghai, Shanghai Municipality, 20040

Other trials in China

About this study

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

This is a study of lasmiditan in healthy Chinese participants. The purposes are:

To evaluate the safety of lasmiditan
To learn more about how the body processes lasmiditan

The study will last up to 50 days for each participant.

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 NCT04081324
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing). Receives: Drug: Placebo
50 milligram (mg) Lasmiditan	Experimental	Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. Receives: Drug: Lasmiditan
100 mg Lasmiditan	Experimental	Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. Receives: Drug: Lasmiditan
200 mg Lasmiditan	Experimental	Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. Receives: Drug: Lasmiditan

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan
PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose
PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan
PK: AUCτ of of Lasmiditan was calculated based on the of Lasmiditan plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when Lasmiditan was administered after single dose (day 1) and multiple doses (Day 10).
Measured: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan after single dose (day 1) and multiple doses (Day 10).
Measured: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan
PK: Time to Maximum Observed Plasma Concentration (tmax) of Lasmiditan after single dose (Day 1) and multiple doses (Day 10).
Measured: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)

Timeline

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

13 Nov 201915 Jun 2020

First posted9 Sep 2019
Study start13 Nov 2019
Primary completion15 Jun 2020
Study completion15 Jun 2020

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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04081324
Sponsor's protocol ID: 17022
Other IDs: H8H-MC-LAIC
Status last verified: Jun 2021
First submitted: 5 Sep 2019
Last updated: 1 Jul 2021
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

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT04081324
Acronym / sponsor ID: 17022
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: 13 Nov 2019 (actual)
Primary completion: 15 Jun 2020 (actual)
Study completion: 15 Jun 2020 (actual)
First posted: 9 Sep 2019 (actual)
Results: Posted 1 Jul 2021

Clinical summary

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

This is a study of lasmiditan in healthy Chinese participants. The purposes are:

To evaluate the safety of lasmiditan
To learn more about how the body processes lasmiditan

The study will last up to 50 days for each participant.

Study design

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

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing).
50 milligram (mg) Lasmiditan	Experimental	Drug: LasmiditanParticipants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
100 mg Lasmiditan	Experimental	Drug: LasmiditanParticipants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
200 mg Lasmiditan	Experimental	Drug: LasmiditanParticipants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Are overtly healthy Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin) males or females, as determined by medical history and physical examination
Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter, inclusive
Are able and willing to give signed informed consent

Key exclusion criteria (5 listed)

Have known allergies to lasmiditan, related compounds or any components of the formulation
Have an abnormal blood pressure and/or pulse rate as determined clinically significant by the investigator
Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
Have a history of central nervous system (CNS) conditions such as strokes, transient ischemic attack, significant head trauma, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increases the risk of participating in the study
Regularly use known drugs of abuse and/or show positive findings on drug screening

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	100 mg Lasmiditan, 200 mg Lasmiditan, 50 milligram (mg) Lasmiditan
PlaceboAdministered orally	Drug	Placebo

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose
PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1).
PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan
Time frame: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)
PK: AUCτ of of Lasmiditan was calculated based on the of Lasmiditan plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when Lasmiditan was administered after single dose (day 1) and multiple doses (Day 10).
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Time frame: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan after single dose (day 1) and multiple doses (Day 10).
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan
Time frame: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)
PK: Time to Maximum Observed Plasma Concentration (tmax) of Lasmiditan after single dose (Day 1) and multiple doses (Day 10).

Results and safety

Results posted to the registry on 1 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	6	6
50 Milligram (mg) Lasmiditan	10	10
100 mg Lasmiditan	10	10
200 mg Lasmiditan	10	10

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan

Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*h/mL)

Measure	50 mg Lasmiditan n = 10	100 mg Lasmiditan n = 10	200 mg Lasmiditan n = 10
Value	385 (48)	829 (34)	1990 (34)

Population analysed: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.

Primary outcome: PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan

Time frame: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose). Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	50 mg Lasmiditan n = 10	100 mg Lasmiditan n = 10	200 mg Lasmiditan n = 10
Day 1	378 (47)	809 (34)	1950 (34)
Day 10	429 (36)	898 (28)	2140 (33)

Population analysed: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.

Primary outcome: PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan

Measure	50 mg Lasmiditan n = 10	100 mg Lasmiditan n = 10	200 mg Lasmiditan n = 10
Day 1	69.6 (48)	154 (37)	359 (33)
Day 10	78.8 (50)	187 (28)	394 (37)

Population analysed: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.

Primary outcome: PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan

Time frame: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose). Median (Full Range). Unit: hours (h)

Measure	50 mg Lasmiditan n = 10	100 mg Lasmiditan n = 10	200 mg Lasmiditan n = 10
Day 1	1.50 (0.50 to 2.50)	1.50 (0.50 to 2.50)	1.50 (1.00 to 2.97)
Day 10	1.75 (0.50 to 2.50)	1.50 (1.00 to 2.00)	1.50 (0.50 to 2.50)

Population analysed: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.

Adverse events

Time frame: Baseline, Up to 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
50 mg Lasmiditan	0 of 10 (0%)	9 of 10 (90%)	0 of 10
100 mg Lasmiditan	0 of 10 (0%)	10 of 10 (100%)	0 of 10
200 mg Lasmiditan	0 of 10 (0%)	8 of 10 (80%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Lasmiditan in people with Healthy, run by Eli Lilly and Company at 1 site in China.

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 3 inclusion and 5 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 1 Jul 2021. 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 China. 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 1 Jul 2021). 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?

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan (time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose). The study lists 4 primary outcomes in all. 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 NCT04081324.

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 1 Jul 2021.