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CompletedNCT03009162Updated Dec 2, 2019Results posted

Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function

A Phase 1 interventional study of Lasmiditan in Migraine, sponsored by Eli Lilly and Company. Completed at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-02.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

This is a multi-center, open-label, non-randomized, parallel-group, adaptive, single dose study.

This study will enroll up to 32 participants using an adaptive design that can include up to 3 groups of 8 participants with different degree of renal impairment and one group of 8 control participants with normal renal function.

Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered in the study.

First, approximately 16 participants will be enrolled with severe renal impairment and matched participants with normal renal function. There will be 8 participants in each of the following groups based on renal function at screening:

  • Group 1: Healthy participants with normal renal function (estimated glomerular filtration rate [eGFR] ≥ 90 milliliters per minute per 1.73 meters squared [mL/min/1.73m²])
  • Group 2: Severe renal impairment participants (eGFR \< 30 mL/min/1.73m²) Based on safety and pharmacokinetic (PK) results from participants with severe renal impairment (Group 2), Group 3 (Moderate Renal Impairment) and Group 4 (Mild Renal Impairment) will be enrolled if substantial change in the exposure of lasmiditan is observed in participants with severe renal impairment.
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Conditions studied

  • Migraine

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03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 16 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Motivated participant and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee
  • Male or female participant
  • A female participant if of childbearing potential - must be willing to use accepted contraceptive regimens from at least 28 days prior to the drug administration, during the study and for at least 60 days after the dose.
  • A male participant with sexual partners who are of child bearing potential must be willing to use accepted contraceptive regimens.
  • A male participant agrees to refrain from sperm donation from drug administration until 3 months after the drug administration
  • Participant aged of at least 18 years
  • Participant with a body mass index (BMI) ≥18.50 kilogram per meter squared (kg/m²) and \< 42.00 kg/m²
  • Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before Day 1 of this study. An ex smoker is defined as someone who completely stopped smoking for at least 6 months before Day 1 of this study
  • Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the participant

Participants with Normal Renal Function:

  • Clinical laboratory values within the laboratory's stated normal range; if not within this range, these must be without any clinical significance
  • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, electrocardiogram [ECG], and urinalysis)
  • For each gender, have to match by age (± 10 years) and weight (± 20%) to the pooled mean values of participants with severe renal impairment
  • Have an eGFR ≥ 90 mL/min/1.73m² calculated using Modification of Diet in Renal Disease (MDRD) equation at screening

Renal Impaired Participants:

  • Considered clinically stable in the opinion of the Investigator
  • Presence of mild renal impairment (eGFR 60-89 mL/min/1.73m²), moderate renal impairment (eGFR 30-59 mL/min/1.73m²), or severe renal impairment (eGFR \< 30 mL/min/1.73m²) calculated using MDRD equation at screening

Exclusion criteria

Exclusion Criteria:

All Participants:

  • Females who are pregnant or are lactating
  • History of significant hypersensitivity to lasmiditan or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
  • Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]) or had a suicide attempt within 6 months prior to screening
  • Presence or history of any disorder (including Parkinson disease) that could interfere with completion of the study based on the opinion of the Principal Investigator
  • Any history of tuberculosis and/or prophylaxis for tuberculosis
  • Positive results to human immunodeficiency virus antigen/antibody (HIV Ag/Ab) Combo, Hepatitis B surface antigen (HBsAG (B) (hepatitis B) or Hepatitis C Virus (HCV [C]) tests
  • Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before Day 1 of this study
  • Females who are pregnant according to a positive pregnancy test
  • Participants who took lasmiditan in the previous 28 days before Day 1 of this study
  • Participants who took an Investigational Product (in another clinical trial) in the previous 28 days before Day 1 of this study
  • Participants who have already participated in this clinical study
  • Participants who donated 50 mL or more of blood in the previous 28 days before Day 1 of this study
  • Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before Day 1 of this study

Participants with Normal Renal Function:

  • Seated pulse rate less than or equal 40 Beats per Minute (bpm) or more than - Seated blood pressure below 90/60 millimeters of mercury (mmHg) or higher than 140/90 mmHg at screening
  • Presence of significant gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs or known to potentiate or predispose to undesired effects
  • History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability, including but not limited to cholecystectomy
  • Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
  • Presence of out-of-range cardiac interval (PR \< 110 milliseconds [msec], PR > 220 msec, QRS \< 60 msec, QRS >119 msec and correct QT interval (QTc) > 450 msec for males and > 460 msec for females) on the screening ECG or other clinically significant ECG abnormalities
  • Positive screening of alcohol and/or drugs of abuse
  • Any clinically significant illness in the previous 28 days before Day 1 of this study

Renal Impaired Participants:

  • Seated pulse rate less than 50 bpm or more than 110 bpm at screening
  • Seated blood pressure below 90/50 mmHg or higher than 180/110 mmHg at screening
  • Currently undergoing any method of dialysis
  • History of renal transplant
  • History or presence, in the opinion of the Investigator, of significant clinically unstable respiratory, cardiovascular, pulmonary, hepatic, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease,
  • Have poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c >10%
  • Require immunosuppressive medications for treatment of immune-mediated renal disease or kidney transplant recipients
  • Evidence of renal carcinoma present at the time of screening
  • Have relevant clinical laboratory abnormalities, including any elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin at screening. If the investigator concludes that there is no safety risk for participants with isolated laboratory abnormalities (eg, those that do not reflect end-organ dysfunction; for example, elevated bilirubin in Gilbert's participants) to participate in the study, such cases need to be discussed and approved by the sponsor's medical monitor prior to study enrollment
  • Presence of clinically significant physical, laboratory, or ECG finding that, in the opinion of the Investigator and/or sponsor, may interfere with any aspect of study conduct or interpretation of results
  • Participants with acute, unstable, or untreated significant medical conditions. Participants requiring treatment for renal impairment or other chronic disease (eg, well-controlled diabetes, hypertension) must be on a stable treatment plan (medicines, doses, and regimens) for at least 2 weeks (except insulin) prior to Day 1 and during the entire study. Small adjustments in the dosages of some concomitant medications may be permitted during the study, and will be discussed on a case-by-case basis. In all cases, the participants' treatment history must be reviewed and their enrollment must be agreed to by both the investigator and the sponsor's medical monitor
  • Positive screening of alcohol and/or drugs of abuse unless results can be explained by a prescription medication
  • Concurrent use of medications known to affect the elimination of serum creatinine (eg, trimethoprim/sulfamethoxazole [Bactrim®] or cimetidine [Tagamet®]) and competitors of renal tubular secretion (eg, probenecid) within 30 days prior to the first dose of study drug or anticipated need for these therapies through the last pharmacokinetic (PK) sample
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Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Renal impaired participants

    Participants received single 200 milligrams (mg) oral tablet of lasmiditan.

    Drug: Lasmiditan

  • Experimental
    Healthy participants

    Participants received single 200 mg oral tablet of lasmiditan.

    Drug: Lasmiditan

Interventions

  • DrugLasmiditan

    200 mg, single oral tablet

    Also known as: LY573144

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What researchers measure

Primary outcomes

  1. Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)

    Maximum observed plasma concentration of lasmiditan.

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose

  2. Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)

    Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose

  3. Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])

    Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC\[0- tlast\]) of lasmiditan.

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose

  4. Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])

    Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity (AUC\[0-inf\]) of lasmiditan.

    Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose

  5. Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t])

    Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine)

    Time frame: Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose

  6. Pharmacokinetics: Fraction of Dose Excreted in Urine (fe)

    Fraction of dose excreted in urine (Ae / dose)

    Time frame: Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose

  7. Pharmacokinetics: Renal Clearance (CLr)

    Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T)

    Time frame: Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Safety was assessed from time of consent through end of study (up to 7 days). Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.

    Time frame: Up To 7 days

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Results

Posted Dec 2, 2019

Participant flow

Participant flow — Overall Study
MilestoneHealthy ParticipantsRenal Impaired Participants
Started88
Received at least 1 dose of study drug88
Completed88
Not completed00

Outcome measures

PrimaryPharmacokinetics: Maximum Observed Plasma Concentration (Cmax)

Maximum observed plasma concentration of lasmiditan.

Time frame:
Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose
Reported as:
Geometric mean · nanogram per milliliter (ng/mL)
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)
nanogram per milliliter (ng/mL)Healthy ParticipantsRenal Impaired Participants
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)259 ± 44293 ± 35
PrimaryPharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)

Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value

Time frame:
Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose
Reported as:
Median · hours (h)
Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)
hours (h)Healthy ParticipantsRenal Impaired Participants
Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)2.50 (1.00 to 3.00)1.78 (0.75 to 3.00)
PrimaryPharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])

Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC\[0- tlast\]) of lasmiditan.

Time frame:
Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose
Reported as:
Geometric mean · nanogram*hour per milliliter (ng*h/mL)
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])
nanogram*hour per milliliter (ng*h/mL)Healthy ParticipantsRenal Impaired Participants
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])1580 ± 441870 ± 32
PrimaryPharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])

Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity (AUC\[0-inf\]) of lasmiditan.

Time frame:
Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose
Reported as:
Geometric mean · ng*h/mL
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])
ng*h/mLHealthy ParticipantsRenal Impaired Participants
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])1600 ± 441890 ± 32
PrimaryPharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t])

Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine)

Time frame:
Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose
Reported as:
Geometric mean · milligrams (mg)
Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t])
milligrams (mg)Healthy ParticipantsRenal Impaired Participants
Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t])4.64 ± 361.85 ± 45
PrimaryPharmacokinetics: Fraction of Dose Excreted in Urine (fe)

Fraction of dose excreted in urine (Ae / dose)

Time frame:
Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose
Reported as:
Geometric mean · Percentage
Pharmacokinetics: Fraction of Dose Excreted in Urine (fe)
PercentageHealthy ParticipantsRenal Impaired Participants
Pharmacokinetics: Fraction of Dose Excreted in Urine (fe)2.32 ± 360.93 ± 45
PrimaryPharmacokinetics: Renal Clearance (CLr)

Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T)

Time frame:
Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose
Reported as:
Geometric mean · Liters/hour (L/h)
Pharmacokinetics: Renal Clearance (CLr)
Liters/hour (L/h)Healthy ParticipantsRenal Impaired Participants
Pharmacokinetics: Renal Clearance (CLr)2.93 ± 280.992 ± 42
SecondaryNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Safety was assessed from time of consent through end of study (up to 7 days). Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.

Time frame:
Up To 7 days
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
ParticipantsHealthy ParticipantsRenal Impaired Participants
Other AEs66
SAEs00

Adverse events

Collected over Up To 7 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Healthy Participants0/8 (0%)0/8 (0%)6/8 (75%)
Renal Impaired Participants0/8 (0%)0/8 (0%)6/8 (75%)
Most frequent other events
Showing 10 of 17
Most frequent other events
EventHealthy ParticipantsRenal Impaired Participants
FatigueGeneral disorders0/83/8
DizzinessNervous system disorders3/81/8
SomnolenceNervous system disorders3/82/8
NauseaGastrointestinal disorders2/80/8
HeadacheNervous system disorders2/80/8
HypoaesthesiaNervous system disorders0/82/8
ParaesthesiaNervous system disorders0/82/8
Orthostatic hypotensionVascular disorders0/82/8
Feeling abnormalGeneral disorders1/80/8
Vessel puncture site bruiseGeneral disorders1/80/8

Baseline characteristics

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

Age, Continuous
Age, Continuous(Years)Healthy ParticipantsRenal Impaired ParticipantsTotal
Mean45.4 ± 12.351.8 ± 15.648.6 ± 14.0
Sex: Female, Male
Sex: Female, Male(Participants)Healthy ParticipantsRenal Impaired ParticipantsTotal
Female448
Male448
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Healthy ParticipantsRenal Impaired ParticipantsTotal
Hispanic or Latino415
Not Hispanic or Latino4711
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Healthy ParticipantsRenal Impaired ParticipantsTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White8816
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Healthy ParticipantsRenal Impaired ParticipantsTotal
Canada8816
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Study locations

2 sites
  • CIUSSS de l'est-de-l'île-de-Montréal - installation Hôpital Maisonneuve-Rosemont
    Montreal, Quebec H3P3P1, Canada
  • Algorithme Pharma
    Mount Royal, Quebec H3P3P1, Canada
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References and documents

Study documents

  • Study protocol · Jan 6, 2017
  • Statistical analysis plan · Feb 15, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03009162
Lead sponsor
Eli Lilly and Company
Collaborators
CoLucid Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 4, 2017
Start date
Apr 1, 2017
Primary completion
Jun 2, 2017
Completion
Jun 2, 2017
Results posted
Dec 2, 2019
Last update
Dec 2, 2019

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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