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
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:
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 →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.
Participants with Normal Renal Function:
Renal Impaired Participants:
Exclusion Criteria:
All Participants:
Participants with Normal Renal Function:
Renal Impaired Participants:
Participants received single 200 milligrams (mg) oral tablet of lasmiditan.
Drug: Lasmiditan
Participants received single 200 mg oral tablet of lasmiditan.
Drug: Lasmiditan
200 mg, single oral tablet
Also known as: LY573144
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
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
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
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
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
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
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
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
| Milestone | Healthy Participants | Renal Impaired Participants |
|---|---|---|
| Started | 8 | 8 |
| Received at least 1 dose of study drug | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
Maximum observed plasma concentration of lasmiditan.
| nanogram per milliliter (ng/mL) | Healthy Participants | Renal Impaired Participants |
|---|---|---|
| Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) | 259 ± 44 | 293 ± 35 |
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
| hours (h) | Healthy Participants | Renal Impaired Participants |
|---|---|---|
| Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) | 2.50 (1.00 to 3.00) | 1.78 (0.75 to 3.00) |
Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC\[0- tlast\]) of lasmiditan.
| nanogram*hour per milliliter (ng*h/mL) | Healthy Participants | Renal Impaired Participants |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast]) | 1580 ± 44 | 1870 ± 32 |
Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity (AUC\[0-inf\]) of lasmiditan.
| ng*h/mL | Healthy Participants | Renal Impaired Participants |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) | 1600 ± 44 | 1890 ± 32 |
Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine)
| milligrams (mg) | Healthy Participants | Renal Impaired Participants |
|---|---|---|
| Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t]) | 4.64 ± 36 | 1.85 ± 45 |
Fraction of dose excreted in urine (Ae / dose)
| Percentage | Healthy Participants | Renal Impaired Participants |
|---|---|---|
| Pharmacokinetics: Fraction of Dose Excreted in Urine (fe) | 2.32 ± 36 | 0.93 ± 45 |
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)
| Liters/hour (L/h) | Healthy Participants | Renal Impaired Participants |
|---|---|---|
| Pharmacokinetics: Renal Clearance (CLr) | 2.93 ± 28 | 0.992 ± 42 |
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.
| Participants | Healthy Participants | Renal Impaired Participants |
|---|---|---|
| Other AEs | 6 | 6 |
| SAEs | 0 | 0 |
Collected over Up To 7 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Participants | 0/8 (0%) | 0/8 (0%) | 6/8 (75%) |
| Renal Impaired Participants | 0/8 (0%) | 0/8 (0%) | 6/8 (75%) |
| Event | Healthy Participants | Renal Impaired Participants |
|---|---|---|
| FatigueGeneral disorders | 0/8 | 3/8 |
| DizzinessNervous system disorders | 3/8 | 1/8 |
| SomnolenceNervous system disorders | 3/8 | 2/8 |
| NauseaGastrointestinal disorders | 2/8 | 0/8 |
| HeadacheNervous system disorders | 2/8 | 0/8 |
| HypoaesthesiaNervous system disorders | 0/8 | 2/8 |
| ParaesthesiaNervous system disorders | 0/8 | 2/8 |
| Orthostatic hypotensionVascular disorders | 0/8 | 2/8 |
| Feeling abnormalGeneral disorders | 1/8 | 0/8 |
| Vessel puncture site bruiseGeneral disorders | 1/8 | 0/8 |
All enrolled participants who received at least one dose of study drug.
| Age, Continuous(Years) | Healthy Participants | Renal Impaired Participants | Total |
|---|---|---|---|
| Mean | 45.4 ± 12.3 | 51.8 ± 15.6 | 48.6 ± 14.0 |
| Sex: Female, Male(Participants) | Healthy Participants | Renal Impaired Participants | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 4 | 4 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Healthy Participants | Renal Impaired Participants | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 5 |
| Not Hispanic or Latino | 4 | 7 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Healthy Participants | Renal Impaired Participants | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 8 | 8 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Healthy Participants | Renal Impaired Participants | Total |
|---|---|---|---|
| Canada | 8 | 8 | 16 |
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Eli Lilly and Company