Study to Evaluate the PK of BMS-927711 in Patient With Migraine During Acute Migraine and Non-migraine Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01445067
First received: September 30, 2011
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the pharmacokinetics (PK) of BMS-927711 during migraine and non-migraine condition.


Condition Intervention Phase
Migraine
Drug: BMS-927711 (CGRP Antagonist)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I, Open-Label, Randomized, Single Sequence Study With Two Dose Groups to Compare the Pharmacokinetics of BMS-927711 in Migraine Subjects During an Acute Migraine Attack and During Non-Migraine Period

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) of BMS-927711 will be derived from plasma concentration versus time [ Time Frame: PK samples will be collected for up to 24 hours after the dosing ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of BMS-927711 will be derived from plasma concentration versus time [ Time Frame: PK samples will be collected for up to 24 hours after the dosing ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours post dose [AUC(0-24)] of BMS-927711 will be derived from plasma concentration versus time [ Time Frame: PK samples will be collected for up to 24 hours after the dosing ] [ Designated as safety issue: No ]
  • Observed plasma concentration at 0.5 hr (C0.5h) of BMS-927711 will be derived from plasma concentration versus time [ Time Frame: PK samples will be collected for up to 24 hours after the dosing ] [ Designated as safety issue: No ]
  • Observed plasma concentration at 2h (C2h) of BMS-927711 will be derived from plasma concentration versus time [ Time Frame: PK samples will be collected for up to 24 hours after the dosing ] [ Designated as safety issue: No ]
  • Apparent total body clearance (CLT/F) of BMS-927711 will be derived from plasma concentration versus time [ Time Frame: PK samples will be collected for up to 24 hours after the dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) will be derived from plasma concentration versus time [ Time Frame: From Day 1 0 hour to Day 2 24 hour time points ] [ Designated as safety issue: No ]
    Individual subject pharmacokinetic parameter values will be derived by non compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses

  • Time of maximum observed plasma concentration (Tmax) will be derived from plasma concentration versus time [ Time Frame: From Day 1 0 hour to Day 2 24 hour time points ] [ Designated as safety issue: No ]
    Individual subject pharmacokinetic parameter values will be derived by non compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses

  • Area under the plasma concentration-time curve from time zero to 24 hours post dose [AUC (0-24)] will be derived from plasma concentration versus time [ Time Frame: From Day 1 0 hour to Day 2 24 hour time points ] [ Designated as safety issue: No ]
    Individual subject pharmacokinetic parameter values will be derived by non compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses

  • Observed plasma concentration at 0.5 hr (C0.5h) will be derived from plasma concentration versus time [ Time Frame: From Day 1 0 hour to Day 2 24 hour time points ] [ Designated as safety issue: No ]
    Individual subject pharmacokinetic parameter values will be derived by non compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses

  • Observed plasma concentration at 2 hr (C2h) will be derived from plasma concentration versus time [ Time Frame: From Day 1 0 hour to Day 2 24 hour time points ] [ Designated as safety issue: No ]
    Individual subject pharmacokinetic parameter values will be derived by non compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses

  • Apparent total body clearance (CLT/F) will be derived from plasma concentration versus time [ Time Frame: From Day 1 0 hour to Day 2 24 hour time points ] [ Designated as safety issue: No ]
    Individual subject pharmacokinetic parameter values will be derived by non compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses


Enrollment: 48
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: BMS-927711 (300 mg) Drug: BMS-927711 (CGRP Antagonist)
Capsule, Oral, 300 mg, Once, One day
Active Comparator: Arm 2: BMS-927711 (600 mg) Drug: BMS-927711 (CGRP Antagonist)
Capsule, Oral, 600 mg, Once, One day

Detailed Description:

Study Classification: Safety CGRP = Calcitonin gene related peptide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with migraine with or without aura who are otherwise healthy as determined by medical history, physical examination, clinical laboratory evaluations and 12-lead electrocardiogram (ECG), will be eligible
  • Men or women [women of childbearing potential (WOCBP) or Women of non childbearing potential (WONCBP)] ages 18-55 years inclusive, with a body mass index (BMI) of 18.0 to 32.0 kg/m2 with not more than 8 migraines a month
  • Patient has at least 1 year history of migraines (with or without aura) including the following:

    1. Meet the diagnostic criteria for migraine with history of at least 1 year (with or without aura) at the screening visit
    2. Migraine attacks with the age of onset prior to 55 years old
    3. Migraine attacks, on average, lasts about 4-72 hours if untreated in the 3 months prior to screening visit
  • 2-8 moderate or severe migraine attacks per month in the 3 months prior to screening visit. The migraine, for which the patient receives treatment during the study, must have at least one of the associated symptoms: nausea, photophobia, phonophobia, or migraine with aura

Exclusion Criteria:

  • Female patient is pregnant/breast-feeding (or is a female expecting to conceive during study period)
  • Patient has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or Human Immunodeficiency Virus (HIV)
  • Patient will be excluded if they take medications for acute migraine more than 10 days per month, had very frequent chronic tension type headaches for 15 or more days per month (or were unable to distinguish between tension-type headaches and migraine)
  • Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
  • Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal absorption
  • Patient has a history or current evidence of any unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
  • Patient has basilar migraine and hemiplegic migraine
  • Patient taking narcotic medication
  • History of alcohol, substance or drug abuse within the last year
  • Uses an opiate as first line acute treatment for migraine attacks
  • History of ergotamine, any acute therapy or triptan intake on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months
  • History of simple analgesic intake on greater than/equal 10 days per month for greater than/equal 3 months
  • History of use of opioid or combination medication intake or butalbital containing analgesic greater than 5 days per month for greater than/equal to 3 months
  • Do not receive migraine relief from a triptan migraine treatment
  • Evidence of renal impairment - calculated creatinine clearance <60ml/min or clinically relevant finding on urinalysis
  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: NCT01445067

Locations
United States, California
California Clinical Trials Medical Group
Glendale, California, United States, 91206
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States, 90806
United States, Florida
Compass Research, Llc
Orlando, Florida, United States, 32806
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45255
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01445067     History of Changes
Other Study ID Numbers: CN170-004
Study First Received: September 30, 2011
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014