HealthyPhase 1NCT03308669

A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate

A Phase 1 study testing Lasmiditan and Topiramate 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.

Official record

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Trial summary

This study will assess the safety, tolerability and blood concentrations of lasmiditan and topiramate together compared to lasmiditan and topiramate separately. Information about any side effects that may occur will be collected. 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 and Topiramate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 16 Oct 2017to 2 Dec 2017
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 healthy males or females (of non-child bearing potential), as determined by medical history and physical examination
Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

Who cannot join

Have known allergies to lasmiditan, topiramate, related compounds or any components of the formulation of lasmiditan or topiramate
Have an abnormal supine blood pressure, defined as systolic blood pressure less than (<) 90 or great (>) 140 millimeters of mercury (mmHg) or diastolic blood pressure <60 or >90 mmHg at screening
Have known or ongoing psychiatric disorders considered clinically significant by the investigator or demonstrate suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS)
Have a clinically significant abnormality in the neurological examination
Have current or a history of orthostatic hypotension (>20-mmHg drop in systolic blood pressure, or >10-mmHg drop in diastolic blood pressure) with or without dizziness and/or syncope at screening or admission to the Clinical Research Unit (CRU) upon repeat testing
Have an estimated glomerular filtration rate using Modification of Diet in Renal Disease <60 milliliter per minute (mL/min) per 1.73 meter squared (m²)
Have a history of glaucoma
Have a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Madison CRU
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: Safety, Tolerability, and Pharmacokinetics of Lasmiditan When Co-administered With Topiramate in Healthy Subjects

Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start of the study and will remain through Day 14.

This study is expected to last approximately 25 days, not including screening. Screening is required within 28 days prior to the start of the study.

Conditions: Healthy
Being tested: Lasmiditan, Placebo, Topiramate

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
TopiramateDrug
Administered orally

Study groups in NCT03308669
Study group	Role	What they receive
Lasmiditan Alone	Experimental	Lasmiditan administered orally, alone Receives: Drug: Lasmiditan
Placebo Alone	Placebo comparator	Placebo administered orally, alone Receives: Drug: Placebo
Topiramate + Lasmiditan	Experimental	Topiramate administered orally, alone, and co-administered with oral lasmiditan Receives: Drug: Lasmiditan; Drug: Topiramate
Topiramate + Placebo	Experimental	Topiramate administered orally, alone, and co-administered with oral placebo Receives: Drug: Placebo; Drug: Topiramate

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 serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline through Day 24

Secondary outcomes (4)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate when administered alone on Day 13 and when coadministered with lasmiditan on Day 14
Measured: Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14
Measured: Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
PK: Area Under the Plasma Concentration Versus Time Curve During One Dosing Interval (AUC [Tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14
PK: Area Under the Plasma Concentration versus Time Curve During One Dosing Interval (AUC [tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14
Measured: Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14
PK: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14
Measured: Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

Timeline

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

16 Oct 20172 Dec 2017

First posted12 Oct 2017
Study start16 Oct 2017
Primary completion2 Dec 2017
Study completion2 Dec 2017

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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03308669
Sponsor's protocol ID: 16925
Other IDs: H8H-MC-LAHT
Status last verified: Jan 2018
First submitted: 9 Oct 2017
Last updated: 27 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, and Pharmacokinetics of Lasmiditan When Co-administered With Topiramate in Healthy Subjects
ClinicalTrials.gov ID: NCT03308669
Acronym / sponsor ID: 16925
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 16 Oct 2017 (actual)
Primary completion: 2 Dec 2017 (actual)
Study completion: 2 Dec 2017 (actual)
First posted: 12 Oct 2017 (actual)
Results: Posted 27 Nov 2019

Clinical summary

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

Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start of the study and will remain through Day 14.

This study is expected to last approximately 25 days, not including screening. Screening is required within 28 days prior to the start of the study.

Study design

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

Arm	Type	Receives
Lasmiditan Alone	Experimental	Drug: LasmiditanLasmiditan administered orally, alone
Placebo Alone	Placebo comparator	Drug: PlaceboPlacebo administered orally, alone
Topiramate + Lasmiditan	Experimental	Drug: Lasmiditan, Drug: TopiramateTopiramate administered orally, alone, and co-administered with oral lasmiditan
Topiramate + Placebo	Experimental	Drug: Placebo, Drug: TopiramateTopiramate administered orally, alone, and co-administered with oral placebo

Who may qualify

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

Key inclusion criteria (2 listed)

Are healthy males or females (of non-child bearing potential), as determined by medical history and physical examination
Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

Key exclusion criteria (8 listed)

Have known allergies to lasmiditan, topiramate, related compounds or any components of the formulation of lasmiditan or topiramate
Have an abnormal supine blood pressure, defined as systolic blood pressure less than (<) 90 or great (>) 140 millimeters of mercury (mmHg) or diastolic blood pressure <60 or >90 mmHg at screening
Have known or ongoing psychiatric disorders considered clinically significant by the investigator or demonstrate suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS)
Have a clinically significant abnormality in the neurological examination
Have current or a history of orthostatic hypotension (>20-mmHg drop in systolic blood pressure, or >10-mmHg drop in diastolic blood pressure) with or without dizziness and/or syncope at screening or admission to the Clinical Research Unit (CRU) upon repeat testing

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 Alone, Topiramate + Lasmiditan
PlaceboAdministered orally	Drug	Placebo Alone, Topiramate + Placebo
TopiramateAdministered orally	Drug	Topiramate + Lasmiditan, Topiramate + Placebo

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 Day 24
A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

4 secondary outcomes

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14
Time frame: Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14
Time frame: Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
PK: Area Under the Plasma Concentration Versus Time Curve During One Dosing Interval (AUC [Tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14
Time frame: Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14
Time frame: Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

Results and safety

Results posted to the registry on 27 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
Treatment Sequence 1: 50 mg Topiramate + Placebo	10	10
Treatment Sequence 2: 50 mg Topiramate + 200 mg Lasmiditan	20	20

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 Day 24. Count of participants. Unit: Participants

Measure	Placebo n = 10	200 mg Lasmiditan n = 20	Topiramate Alone n = 30	50 mg Topiramate + 200 mg Lasmiditan n = 20	50 mg Topiramate + Placebo n = 10
Value	0	0	0	0	0

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

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 24 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
200 mg Lasmiditan	0 of 20 (0%)	8 of 20 (40%)	0 of 20
Placebo	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Topiramate Alone	0 of 30 (0%)	5 of 30 (16.7%)	0 of 30
50 mg Topiramate + 200 mg Lasmiditan	0 of 20 (0%)	8 of 20 (40%)	0 of 20
50 mg Topiramate + Placebo	0 of 10 (0%)	2 of 10 (20%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
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 Lasmiditan and Topiramate 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 8 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 27 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 27 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 through Day 24). 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 NCT03308669.

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 27 Nov 2019.