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A Study of Lasmiditan in Healthy Chinese Participants
Phase 1 trial testing Lasmiditan in Healthy in 36 participants. Completed in 15 June 2020.
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 36 |
| Start date | 13 November 2019 |
| Primary completion | 15 June 2020 |
| Estimated completion | 15 June 2020 |
| Sites | 1 location across China |
Eli Lilly and Company — full company profile →
Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1).
| Group | Value | 95% CI |
|---|---|---|
| 50 mg Lasmiditan | 385 | ± 48 |
| 100 mg Lasmiditan | 829 | ± 34 |
| 200 mg Lasmiditan | 1990 | ± 34 |
PK: AUCτ of of Lasmiditan was calculated based on the of Lasmiditan plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau \[τ\]) when Lasmiditan was administered after single dose (day 1) and multiple doses (Day 10).
| Group | Value | 95% CI |
|---|---|---|
| 50 mg Lasmiditan | 378 | ± 47 |
| 100 mg Lasmiditan | 809 | ± 34 |
| 200 mg Lasmiditan | 1950 | ± 34 |
| Group | Value | 95% CI |
|---|---|---|
| 50 mg Lasmiditan | 429 | ± 36 |
| 100 mg Lasmiditan | 898 | ± 28 |
| 200 mg Lasmiditan | 2140 | ± 33 |
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan after single dose (day 1) and multiple doses (Day 10).
| Group | Value | 95% CI |
|---|---|---|
| 50 mg Lasmiditan | 69.6 | ± 48 |
| 100 mg Lasmiditan | 154 | ± 37 |
| 200 mg Lasmiditan | 359 | ± 33 |
| Group | Value | 95% CI |
|---|---|---|
| 50 mg Lasmiditan | 78.8 | ± 50 |
| 100 mg Lasmiditan | 187 | ± 28 |
| 200 mg Lasmiditan | 394 | ± 37 |
PK: Time to Maximum Observed Plasma Concentration (tmax) of Lasmiditan after single dose (Day 1) and multiple doses (Day 10).
| Group | Value | 95% CI |
|---|---|---|
| 50 mg Lasmiditan | 1.50 | 0.50 – 2.50 |
| 100 mg Lasmiditan | 1.50 | 0.50 – 2.50 |
| 200 mg Lasmiditan | 1.50 | 1.00 – 2.97 |
| Group | Value | 95% CI |
|---|---|---|
| 50 mg Lasmiditan | 1.75 | 0.50 – 2.50 |
| 100 mg Lasmiditan | 1.50 | 1.00 – 2.00 |
| 200 mg Lasmiditan | 1.50 | 0.50 – 2.50 |
Time frame: Baseline, Up to 4 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | 50 mg Lasmiditan | 100 mg Lasmiditan | 200 mg Lasmiditan |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | — | — | — | — |
| Heart rate decreased | Investigations | — | — | — | — |
| Sinus bradycardia | Cardiac disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Blood pressure decreased | Investigations | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Atrioventricular block first degree | Cardiac disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Asthenia | General disorders | — | — | — | — |
| Heart rate increased | Investigations | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — |
| White blood cell count decreased | Investigations | — | — | — | — |
| White blood cells urine positive | Investigations | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Mouth ulceration | Gastrointestinal disorders | — | — | — | — |
| Chills | General disorders | — | — | — | — |
| Malaise | General disorders | — | — | — | — |
| Puncture site swelling | General disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — |
| Blood pressure increased | Investigations | — | — | — | — |
| Body temperature increased | Investigations | — | — | — | — |
| Electrocardiogram qt prolonged | Investigations | — | — | — | — |
| Haematocrit decreased | Investigations | — | — | — | — |
| Haemoglobin decreased | Investigations | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — |
| Lymphocyte percentage decreased | Investigations | — | — | — | — |
| Neutrophil percentage decreased | Investigations | — | — | — | — |
| Neutrophil percentage increased | Investigations | — | — | — | — |
| Protein urine present | Investigations | — | — | — | — |
| Red blood cell count decreased | Investigations | — | — | — | — |
| Red blood cells urine positive | Investigations | — | — | — | — |
| Urinary casts | Investigations | — | — | — | — |
Data from ClinicalTrials.gov NCT04081324 adverse events section.
This is a study of lasmiditan in healthy Chinese participants. The purposes are: * To evaluate the safety of lasmiditan * To learn more about how the body processes lasmiditan The study will last up to 50 days for each participant.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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/NCT04081324.
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