Phase 1
Completed N=70
A Study of Multiple Doses of Lasmiditan in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT03252015 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
Summary
The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it.
When drugs are taken together, one or all of the drugs used in combination may be affected. This study will also evaluate the concentrations in the blood of a probe drug cocktail taken alone and in combination with lasmiditan. Information about any side effects that may occur will also be collected.
The study has two parts. Participants will only enroll in one part. This study will last about 25 days for group 1 and 22 days for group 2, not including screening. Screening is required within 28 days prior to the start of the study.
This study is for research purposes only and is not intended to treat any medical condition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1 |
349; 750 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7 |
353; 808 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1 |
2070; 4530 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7 |
2160; 4690 | — |
| SECONDARY Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score |
0.0; 0.2; 0.0; 0.1; 0.0; 0.0 | — |
| SECONDARY Physician Withdrawal Checklist (PWC)Total Score |
0.2; 0.0; 0.0; 0.1; 0.0; 0.1 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1 |
407; 964 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7 |
641; 1500 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam |
10. | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7 |
10.1; 9.45 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy males or females, as determined by medical history and physical examination
- Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening
Exclusion Criteria
- Have participated, within the last 30 days, in a clinical study involving an Investigational Product (IP)
- Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan
- Have clinically significant abnormality in the 12-lead ECG, including corrected QT interval (QTc) with Fridericia's correction (QTcF) greater than (>) 450 milliseconds (ms) for men or >470 ms for women or any abnormality that in the opinion of the investigator increases the risk of participating in the study (not limited to significant bradycardia or heart block)
- History of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression), have a recent history of a suicide attempt (30 days within screening visit and any time between screening visit and baseline); or are clinically judged by the investigator to be at risk for suicide
- History of hypoglycemia
- Known history of glucose-6-phosphate dehydrogenase deficiency
- Are taking a concomitant medication or a dietary substance that affects cytochrome P450 (CYP)1A2, CYP2C9, and/or CYP3A isotypes within 14 days of screening
Data sourced from ClinicalTrials.gov (NCT03252015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.