Adults 20 to 64, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationPrimary· Baseline up to Day 20
The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
Group
Value
95% CI
Placebo: Japanese
0
Placebo: Caucasian
0
2 x Placebo: Japanese
0
50 mg Lasmiditan: Japanese
0
50 mg Lasmiditan: Caucasian
0
100 mg Lasmiditan: Japanese
0
100 mg Lasmiditan: Caucasian
0
200 mg Lasmiditan: Japanese
0
200 mg Lasmiditan: Caucasian
0
400 mg Lasmiditan: Japanese
0
2 X 200 mg Lasmiditan: Japanese
0
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each PeriodSecondary· Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose
PK: AUC(0-∞) of Lasmiditan in Each Period was evaluated.
Group
Value
95% CI
50 mg Lasmiditan: Japanese
362
± 46
50 mg Lasmiditan: Caucasian
366
± 78
100 mg Lasmiditan: Japanese
791
± 22
100 mg Lasmiditan: Caucasian
826
± 70
200 mg Lasmiditan: Japanese
1540
± 26
200 mg Lasmiditan: Caucasian
2120
± 50
400 mg Lasmiditan: Japanese
3780
± 32
2 X 200 mg Lasmiditan: Japanese
3500
± 26
PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each PeriodSecondary· Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose
PK: Cmax of Lasmiditan in Each Period was evaluated.
Group
Value
95% CI
50 mg Lasmiditan: Japanese
54.1
± 35
50 mg Lasmiditan: Caucasian
52.4
± 84
100 mg Lasmiditan: Japanese
122
± 18
100 mg Lasmiditan: Caucasian
101
± 94
200 mg Lasmiditan: Japanese
249
± 39
200 mg Lasmiditan: Caucasian
309
± 51
400 mg Lasmiditan: Japanese
680
± 40
2 X 200 mg Lasmiditan: Japanese
519
± 24
Adverse events — posted to ClinicalTrials.gov
Time frame: Up To 20 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in healthy Japanese and Caucasian participants. The study will also investigate how much lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan when given to Japanese and Caucasians. The study will last up to 47 days for each participant.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 29 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03579940.