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A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03310411
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 11, 2017
First Posted Date  ICMJE October 16, 2017
Last Update Posted Date January 19, 2018
Actual Study Start Date  ICMJE October 17, 2017
Actual Primary Completion Date December 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
Pharmacodynamics (PD): Systolic Blood Pressure (SBP) [ Time Frame: Baseline through 24 hours after administration of study drug in each period ]
Systolic Blood Pressure (SBP) per 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03310411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
  • Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan, Sumatriptan, and Lasmiditan + Sumatriptan [ Time Frame: Baseline through 48 hours after administration of study drug in each period ]
    PK: Cmax of Lasmiditan, Sumatriptan, and Lasmiditan + Sumatriptan
  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0 ∞]) of Lasmiditan, Sumatriptan, and Lasmiditan + Sumatriptan [ Time Frame: Baseline through 48 hours after administration of study drug in each period ]
    PK: AUC(0 ∞) of Lasmiditan, Sumatriptan and Lasmiditan + Sumatriptan
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants
Official Title  ICMJE A Randomized, Double-Blind, Four-Period, Crossover Study to Evaluate the Cardiovascular Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Subjects
Brief Summary

The purpose of this study is to assess whether taking lasmiditan and sumatriptan together will have any additional effects on heart rate and blood pressure compared to taking lasmiditan and sumatriptan individually. This study will also look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it when these two drugs are taken together.

This study will last about 21 days, not including the screening. Participants will spend 16 days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is required within 28 days prior to the start of the study.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Lasmiditan
    Administered orally
    Other Name: LY573144
  • Drug: Sumatriptan
    Administered orally
  • Drug: Placebo for Lasmiditan
    Administered orally
  • Drug: Placebo for Sumatriptan
    Administered orally
Study Arms  ICMJE
  • Experimental: Lasmiditan + Sumatriptan (A)
    Single oral dose of lasmiditan and single oral dose of sumatriptan in one of four treatment periods.
    Interventions:
    • Drug: Lasmiditan
    • Drug: Sumatriptan
  • Experimental: Lasmiditan + Placebo (B)
    Single oral dose of lasmiditan and single oral dose of placebo in one of four treatment periods.
    Interventions:
    • Drug: Lasmiditan
    • Drug: Placebo for Sumatriptan
  • Active Comparator: Sumatriptan + Placebo (C)
    Single oral dose of sumatriptan and single oral dose of placebo in one of four treatment periods.
    Interventions:
    • Drug: Sumatriptan
    • Drug: Placebo for Lasmiditan
  • Placebo Comparator: Placebo + Placebo (D)
    Oral doses of placebo in one of four treatment periods.
    Interventions:
    • Drug: Placebo for Lasmiditan
    • Drug: Placebo for Sumatriptan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 23, 2017
Actual Primary Completion Date December 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

Exclusion Criteria:

  • Have known allergies to Lasmiditan, Sumatriptan, related compounds, or any components of the formulations of Lasmiditan and Sumatriptan
  • Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias
  • Have a history, signs, or symptoms of arrhythmia or Wolff Parkinson White syndrome that could affect the participant's safety
  • Have an estimated glomerular filtration rate (eGFR) of less than (<) 60 milliliter per minute (mL/min) per 1.73 m²
  • Have a resting systolic blood pressure (SBP) greater than (>) 135 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) >85 mmHg at screening
  • Have a supine pulse rate (PR) of <50 or >90 beats per minute (bpm) at screening
  • Have a history, signs, or symptoms of vasospastic coronary artery disease
  • Have known or ongoing neuropsychiatric disorders (for example, manic depressive illness, schizophrenia, depression) considered as clinically significant by the investigator
  • Use of monoamine oxidase-A inhibitors and other drugs associated with serotonin within the 3 months prior to the first dosing occasion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03310411
Other Study ID Numbers  ICMJE 16926
H8H-MC-LAHU ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP