HealthyPhase 1NCT03465436

A Study of Lasmiditan on the Heart in Healthy Participants

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

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

The purpose of this study was to determine how two doses of lasmiditan affected the heart in healthy participants. The study also evaluated how much lasmiditan got into the blood stream and how long it took the body to get rid of it. Information about side effects was collected. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lasmiditan and Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteGermany
Study dates: 16 Sep 2011to 20 Dec 2011
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)
In good physical and mental health as determined by the following:
Complete medical history
Complete physical examination
Vital signs including blood pressure (supine and standing), heart rate (supine and standing), respiratory rate, and temperature
Standard 12-lead ECG (triplicate ECG), followed by a 24-hour Holter ECG for arrhythmia monitoring
Clinical laboratory tests

Who cannot join

Any of the following cardiac abnormalities on safety screening ECG:
QTcF interval >430 milliseconds (ms) for males, >450 ms for females
Unusual T wave morphology or flattened low voltage T waves
PR interval >240 ms or <110 ms
Second-degree or third-degree atrioventricular block
ECG evidence of complete left or right bundle branch block

Show all 16Show fewer

Intraventricular conduction delay or QRS duration >110 ms
Supine resting heart rate <45 beats per minute (bpm) or >90 bpm
Pathological Q-waves
Evidence of ventricular pre-excitation
Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease
Participants with a family history of Long QT syndrome
History of allergic hypersensitivity to lasmiditan or any component of the formulations
History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
Participants with a history of postural hypotension or fainting
Participant is not able to understand and comply with study requirements, instructions and study restrictions

Trial locations and contacts

1 site in 1 country.

Germany1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Berlin, 14050

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Repolarization Duration as Well as Other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) With Those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects

Conditions: Healthy
Being tested: Lasmiditan, Placebo, Moxifloxacin

What participants receive

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

LasmiditanDrug
Also called LY573144
100 mg administered orally (PO)
LasmiditanDrug
Also called LY573144
400 mg administered PO
PlaceboDrug
Placebo administered for lasmiditan or moxifloxacin
MoxifloxacinDrug
400 mg moxifloxacin administered PO

Study groups in NCT03465436
Study group	Role	What they receive
100 milligrams (mg) Lasmiditan	Experimental	A single, PO dose of 100 mg lasmiditan administered on Day 1 in one of four treatment periods. Receives: Drug: Lasmiditan
400 mg Lasmiditan	Experimental	A single, PO dose of 400 mg lasmiditan administered on Day 1 in one of four treatment periods. Receives: Drug: Lasmiditan
Placebo	Placebo comparator	Placebo for lasmiditan and placebo for moxifloxacin administered on Day 1 in one of four treatment periods. Receives: Drug: Placebo
Moxifloxacin	Active comparator	A single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods. Receives: Drug: Moxifloxacin

What is being measured

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

Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.
Measured: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

Secondary outcomes (7)

Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for participant pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Measured: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
ECGs were used to calculate cardiac intervals. The RR interval is the time between two R waves.
Measured: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
ECGs were used to calculate cardiac intervals. The QRS interval is the time the segment of the ECG that corresponds to depolarization of the ventricles.
Measured: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
Heart rate was determined during ambulatory blood pressure monitoring (ABPM).
Measured: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
ECGs were assessed for morphology abnormalities or changes in QTcf interval greater than 450 milliseconds by a board-certified cardiologist
Measured: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.
Measured: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan.
Measured: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

Timeline

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

16 Sep 201120 Dec 2011

First posted14 Mar 2018
Study start16 Sep 2011
Primary completion20 Dec 2011
Study completion20 Dec 2011

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: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03465436
Sponsor's protocol ID: 16900
Other IDs: H8H-CD-LAHP, COL-MIG-105, 2011-003229-88
Status last verified: Mar 2018
First submitted: 5 Feb 2018
Last updated: 31 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Repolarization Duration as Well as Other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) With Those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects
ClinicalTrials.gov ID: NCT03465436
Acronym / sponsor ID: 16900
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: CoLucid Pharmaceuticals
Study start: 16 Sep 2011 (actual)
Primary completion: 20 Dec 2011 (actual)
Study completion: 20 Dec 2011 (actual)
First posted: 14 Mar 2018 (actual)
Results: Posted 31 Jan 2020

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
100 milligrams (mg) Lasmiditan	Experimental	Drug: LasmiditanA single, PO dose of 100 mg lasmiditan administered on Day 1 in one of four treatment periods.
400 mg Lasmiditan	Experimental	Drug: LasmiditanA single, PO dose of 400 mg lasmiditan administered on Day 1 in one of four treatment periods.
Placebo	Placebo comparator	Drug: PlaceboPlacebo for lasmiditan and placebo for moxifloxacin administered on Day 1 in one of four treatment periods.
Moxifloxacin	Active comparator	Drug: MoxifloxacinA single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)
In good physical and mental health as determined by the following:

Key exclusion criteria (16 listed)

Any of the following cardiac abnormalities on safety screening ECG:
Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease
Participants with a family history of Long QT syndrome
History of allergic hypersensitivity to lasmiditan or any component of the formulations
History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse

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: LY573144100 mg administered orally (PO)	Drug	100 milligrams (mg) Lasmiditan
LasmiditanAlso: LY573144400 mg administered PO	Drug	400 mg Lasmiditan
PlaceboPlacebo administered for lasmiditan or moxifloxacin	Drug	Placebo
Moxifloxacin400 mg moxifloxacin administered PO	Drug	Moxifloxacin

Primary outcome

Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
Time frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.

7 secondary outcomes

Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
Time frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
Time frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
Time frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
Time frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
Time frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
Time frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan
Time frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

Results and safety

Results posted to the registry on 31 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 ABDC	14	14
Sequence 2 BCAD	14	14
Sequence 3 CDBA	14	13
Sequence 4 DACB	14	14

Primary outcome: Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin

Time frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose. Mean (Standard Deviation). Unit: milliseconds

Measure	100 mg Lasmiditan n = 52	400 mg Lasmiditan n = 55	Placebo n = 54	Moxifloxacin n = 52
30 minutes postdose	-8.90 (7.20)	-9.27 (6.29)	-5.49 (5.52)	1.90 (8.69)
1 hour postdose	-7.42 (5.83)	-4.58 (8.13)	-3.94 (5.15)	8.36 (6.51)
1.5 hours postdose	-7.63 (5.98)	-3.07 (7.91)	-3.68 (4.66)	7.63 (6.32)
2 hours postdose	-6.96 (7.08)	-1.12 (8.10)	-3.83 (5.28)	8.16 (7.21)
2.5 hours postdose	-5.26 (7.36)	0.15 (8.67)	-2.89 (4.99)	8.12 (7.15)
3 hours postdose	-2.81 (6.95)	2.06 (8.18)	-2.04 (5.71)	10.01 (6.42)
3.5 hours postdose	-2.39 (7.63)	3.58 (6.88)	-1.85 (4.59)	10.37 (7.09)
4 hours postdose	-2.12 (6.89)	4.77 (7.49)	-2.34 (5.65)	9.39 (5.85)

100 mg Lasmiditan vs Placebo: LS Mean: -3.50 (90% CI -5.41 to -1.59), Mixed Models Analysis
100 mg Lasmiditan vs Placebo: LS Mean: -3.54 (90% CI -5.18 to -1.89), Mixed Models Analysis
100 mg Lasmiditan vs Placebo: LS Mean: -4.10 (90% CI -5.77 to -2.43), Mixed Models Analysis

Population analysed: All randomized participants who received at least 1 dose of study drug and have evaluable QTcF data.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 75 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
100 mg Lasmiditan	0 of 52 (0%)	21 of 52 (40.4%)	0 of 52
400 mg Lasmiditan	0 of 55 (0%)	33 of 55 (60%)	0 of 55
Placebo	0 of 54 (0%)	7 of 54 (13%)	0 of 54
Moxifloxacin	1 of 52 (1.9%)	9 of 52 (17.3%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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 Moxifloxacin in people with Healthy, run by Eli Lilly and Company at 1 site in Germany.

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 7 inclusion and 16 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 31 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 Germany. 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 31 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?

Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin (time frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose). 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 NCT03465436.

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 31 Jan 2020.