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Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
SNBL Clinical Pharmacology Center, Inc.
Information provided by (Responsible Party):
CoLucid Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03076970
First received: March 2, 2017
Last updated: May 10, 2017
Last verified: May 2017
  Purpose
This is a randomized, double-blind, three-period, cross-over study to investigate the effect of sumatriptan (Imitrex) 100 mg on the pharmacodynamics and pharmacokinetics of lasmiditan 200 mg.

Condition Intervention Phase
Acute Treatment of Migraine Drug: lasmiditan 200 mg Drug: Sumatriptan Drug: matching placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Three Period, Cross-Over Study to Evaluate the Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan (Imitrex) in Healthy Male and Female Subjects

Resource links provided by NLM:


Further study details as provided by CoLucid Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacodynamics- change from pre-dose to 24 hours in vital signs [ Time Frame: Sequential timepoints - Predose and 1, 2, 4, 8 and 24 hours postdose ]
    serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.

  • Pharmacodynamics- change from pre-dose to 24 hours in ECGs [ Time Frame: Sequential timepoints - Predose and 1, 1.5, 2, 2.5, 4, 8 and 24 hours postdose. ]
    serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together

  • Pharmacodynamics - Adverse events [ Time Frame: Each dosing period - from pre-dose through 30 hours post dose ]
    Adverse events reported when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together


Secondary Outcome Measures:
  • Pharmacokinetics - Cmax [ Time Frame: Pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period ]
    Maximum plasma concentration of lasmiditan alone compared to lasmiditan in combination with sumatriptan

  • Pharmacokinetics - AUC0-t [ Time Frame: Pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period ]
    Area under the plasma concentration vs. time curve from time 0 to the time t of the last quantifiable concentration, calculated by means of the mixed log-linear trapezoidal rule of lasmiditan alone compare to lasmiditan in combination with sumatriptan

  • Pharmacokinetics - tmax [ Time Frame: Pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period ]
    Time to maximum plasma concentration of lasmiditan alone compared to lasmiditan in combination with sumatriptan


Enrollment: 42
Actual Study Start Date: March 21, 2017
Study Completion Date: April 13, 2017
Primary Completion Date: April 13, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lasmiditan 200 mg
single oral tablet
Drug: lasmiditan 200 mg
drug including single placebo tablet
Drug: matching placebo
single oral tablet -given with single lasmiditan tablet and with single sumatriptan tablet.
Active Comparator: Sumatriptan 100 mg
single oral tablet
Drug: Sumatriptan
drug including single placebo tablet
Other Name: imitrex
Drug: matching placebo
single oral tablet -given with single lasmiditan tablet and with single sumatriptan tablet.
Experimental: Combination of lasmiditan and sumatriptan
single oral tablet of each
Drug: lasmiditan 200 mg
drug including single placebo tablet
Drug: Sumatriptan
drug including single placebo tablet
Other Name: imitrex

Detailed Description:
This is a randomized, double-blind, three-period, cross-over study to investigate the effect of single doses of sumatriptan (Imitrex) 100 mg on the pharmacodynamics of single doses of lasmiditan 200 mg. The study will last approximately 6 weeks including up to 3 weeks for screening and 22 days on study. Screening will be conducted within approximately 21 days of the first dose of study medication. Each dosing period will last 3 days (Day 1, Day 1, and Day 2). A wash-out period of 6 days will take place between each dose. The End of Study Visit (EoS) will take place 5 (+/- 2) days after the third dosing period is completed.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female aged 18-60 years, inclusive.
  2. Able and willing to give written informed consent.
  3. BMI between 18 and 32 kg/m2, inclusive.
  4. Subjects must be able to refrain from consuming xanthine, quinine and caffeine containing beverages, and must refrain from prolonged intensive physical exercise during the study (from 72 hours prior to dosing until the last study visit).
  5. Women must be:

    • not pregnant
    • not breast-feeding
    • not planning to become pregnant during the study
  6. All females must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in on Day -1 of each period. All women must agree to use an adequate method of contraception during the study and for 30 days following the end-of-study visit.
  7. Male subjects must agree to utilize a highly effective method of contraception (condom plus spermicide) during heterosexual intercourse from clinic admission until 30 days following the end of study visit.
  8. Male subjects must agree to refrain from sperm donation from clinic admission until at least 30 days following the end of study visit.
  9. Subjects must be able to swallow multiple pills simultaneously.
  10. Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study.

Exclusion Criteria:

  1. Any medical condition, clinical laboratory test or other reason which in the judgment of the Investigator or designee makes the subject unsuitable for the study.
  2. Any clinically significant abnormalities (as determined by the Principal Investigator or designee) in hematology, blood chemistry and/or urinalysis lab tests at screening or at Period 1 D-1.
  3. Known hypersensitivity to lasmiditan, sumatriptan (Imitrex), or to any excipient of lasmiditan or sumatriptan (Imitrex) oral tablets.
  4. Use of any prescription medication, including MAO-A inhibitors and other drugs associated with serotonin syndrome, within 14 days prior to dosing (except hormonal contraceptives) except for 5-HT1 (serotonin) agonists and selective serotonin reuptake inhibitors.
  5. History, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including but not limited to angina pectoris, myocardial infarction, silent myocardial ischemia (Ischemic cardiac syndromes), stroke, transient ischemic attacks (cerebrovascular syndromes), and ischemic bowel disease (peripheral vascular disease).
  6. History, symptoms, or signs of vasospastic coronary artery disease.
  7. History, symptoms, or signs of arrhythmia or Wolff Parkinson White (WPW) syndrome that could affect the subject's safety in the opinion of the Investigator or designee.
  8. History, symptoms, or signs of severe hepatic impairment.
  9. History, symptoms, or signs of diabetes.
  10. History within the previous 3 years or current evidence of abuse (according to DSM-IV criteria) of any drug, prescription or illicit, or alcohol; a positive urine screen for drugs of abuse or breathalyzer alcohol test.
  11. Positive urinary test for drugs of abuse and/or alcohol breath test at Screening and/or at check-in on Day -1 of each Period. Cotinine will be included at screening only.
  12. History of orthostatic hypotension with or without syncope.
  13. Supine systolic blood pressure (BP) > 135 mm Hg, diastolic BP > 85 mm Hg, respiratory rate >20 breaths per minute, pulse >90 beats per minute, or temperature >37.5º at Screening. Low values on any vital sign measurement will be assessed at the discretion of the Investigator or designee. For orthostatic vital signs, any decrease in systolic and/or diastolic blood pressure great than 20 mmHg. Any other changes will be assessed at the discretion of the Investigator or designee.
  14. ECG changes including QT interval prolongation and congenital long QT syndrome.
  15. Electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, or other medicinal products that lead to QT prolongation.
  16. Any clinically significant alanine aminotransferase (ALT), alkaline phosphatase (AP), aspartate aminotransferase (AST), or bilirubin abnormalities judged by the Investigator or designee at Screening.
  17. Treatment with centrally active drugs or those affecting peripheral cholinergic transmission within 3 months of study entry.
  18. Consumption of grapefruit, grapefruit juice, Seville oranges, Seville orange juice, or beverages containing any of these juices or consumption of members of the mustard green family (including kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard (i.e. seeds, greens, spice or the condiment)) within 72 hours of dosing.
  19. Tobacco or nicotine users except subjects who stopped using tobacco or nicotine 1 year or more before signing the informed consent.
  20. Subject is at imminent risk of suicide or had a suicide attempt within 6 months prior to the screening visit.
  21. Participation in any clinical trial of an experimental drug or device in the previous 30 days.
  22. Positive Hepatitis C antibody, Hepatitis B surface antigen, or positive human immunodeficiency virus (HIV) antibody.
  23. Subjects who donated plasma in the 7 days or blood in the 3 months preceding study drug administration.
  24. Subjects with an inability to communicate well with the Investigator or designee and study staff (i.e., language problem, poor mental development or impaired cerebral function).
  25. Inability to fast or consume the food provided in the study.
  26. Relatives of or staff directly reporting to the Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03076970

Locations
United States, Maryland
SNBL Clinical Pharmacology Unit
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
CoLucid Pharmaceuticals
SNBL Clinical Pharmacology Center, Inc.
  More Information

Responsible Party: CoLucid Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03076970     History of Changes
Other Study ID Numbers: COL MIG-118
Study First Received: March 2, 2017
Last Updated: May 10, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sumatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017