A Study of Multiple Doses of Lasmiditan in Healthy Participants

Healthy Clinical Trial

Official title:

Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Drug-Drug Interaction Study of Lasmiditan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252015
• Other study ID #: 16859
• Secondary ID: H8H-MC-LAHE
• Status: Completed
• Phase: Phase 1
• Start date: August 15, 2017
• Est. completion date: January 2, 2018

Study information

• Verified date: March 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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• Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Probe Drug Cocktail
Administered orally
• Lasmiditan
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
United States	Covance Daytona Beach	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.	Baseline through 14 days after last administration of study drug
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1	PK: Cmax of lasmiditan	Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7	PK: Cmax of lasmiditan Day 7	Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose
Secondary	Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1	PK: AUCtau of lasmiditan	Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose
Secondary	Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7	PK AUCtau of lasmiditan	Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose
Secondary	Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score	BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort.	PreDose Day 7 and Day 21
Secondary	Physician Withdrawal Checklist (PWC)Total Score	Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Day 7 and Day 21 at anytime
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1	Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.	Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7	Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.	Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam	PK: Cmax of midazolam.	Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose,
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7	PK of midazolam.	Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose