Phase 1
Completed N=42
Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Participants
Source: ClinicalTrials.gov NCT03076970 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Systolic Blood Pressure — 0.6; -2.3; -0.1 millimeters of mercury (mmHg)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Systolic Blood Pressure |
0.6; -2.3; -0.1 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Diastolic Blood Pressure |
-1.3; -1.1; 0.6 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Pulse Rate |
-2.5; -1.0; 1.8 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Temperature |
0.0; -0.0; -0.1 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Respiratory Rate |
0.2; 0.2; 0.7 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Heart Rate |
-0.8; -1.3; 0.4 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) PR Duration |
-4.5; -2.5; -1.6 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QRS Duration |
-0.5; -1.7; -0.6 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcB - Bazett's Correction Formula |
-2.7; -3.3; 1.6 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcF - Fridericia's Correction Formula |
-1.8; -2.0; 1.3 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QT Duration |
0.1; 1.0; 0.6 | — |
| PRIMARY Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) RR Duration |
14.1; 24.2; -4.1 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
24; 16; 28; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics - Cmax |
268; 238 | — |
| SECONDARY Pharmacokinetics - AUC0-t |
1730; 1650 | — |
| SECONDARY Pharmacokinetics - Tmax |
2.00; 3.00 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female aged 18-60 years, inclusive.
- Able and willing to give written informed consent.
- Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²), inclusive.
- Participants 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 end of study).
- Women must be:
- not pregnant
- not breast-feeding
- not planning to become pregnant during the study
- 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.
- Male participants 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.
- Male participants must agree to refrain from sperm donation from clinic admission until at least 30 days following the end of study.
- Participants must be able to swallow multiple pills simultaneously.
- Participants must be able to understand the requirements of the study and must be willing to comply with the requirements of the study.
Exclusion Criteria
- Any medical condition, clinical laboratory test or other reason which in the judgment of the Investigator or designee makes the participant unsuitable for the study.
- 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.
- Known hypersensitivity to lasmiditan, sumatriptan (Imitrex), or to any excipient of lasmiditan or sumatriptan (Imitrex) oral tablets.
- Use of any prescription medication, including monoamine oxidase A (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.
- 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).
- History, symptoms, or signs of vasospastic coronary artery disease.
- History, symptoms, or signs of arrhythmia or Wolff Parkinson White (WPW) syndrome that could affect the participant's safety in the opinion of the Investigator or designee.
- History, symptoms, or signs of severe hepatic impairment.
- History, symptoms, or signs of diabetes.
- History within the previous 3 years or current evidence of abuse (according to Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition [DSM-IV] criteria) of any drug, prescription or illicit, or alcohol; a positive urine screen for drugs of abuse or breathalyzer alcohol test.
- 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.
- History of orthostatic hypotension with or without syncope.
- Supine systolic blood pressure (BP) > 135 millimeters of mercury (mmHg), 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.
- Electrocardiogram (ECG) changes including QT interval prolongation and congenital long QT syn
Data sourced from ClinicalTrials.gov (NCT03076970). 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.