A Study of Multiple Doses of Lasmiditan in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | August 15, 2017 |
| End Date: | January 2, 2018 |
Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Drug-Drug Interaction Study of Lasmiditan
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 how much lasmiditan and its breakdown products get into the
bloodstream after taking one dose alone and after taking lasmiditan together with a probe
drug cocktail. 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.
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 how much lasmiditan and its breakdown products get into the
bloodstream after taking one dose alone and after taking lasmiditan together with a probe
drug cocktail. 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.
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- Have previously completed or withdrawn from this study or any other study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
We found this trial at
1
site
Daytona Beach, Florida 32117
Principal Investigator: Hugh Coleman, MD
Phone: 866-429-3700
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