MigrainePhase 1NCT01445067
Study to Evaluate the PK of BMS-927711 in Patient With Migraine During Acute Migraine and Non-migraine Condition
A Phase 1 study testing BMS-927711 (CGRP Antagonist) in people with Migraine, run by Pfizer at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of BMS-927711 during migraine and non-migraine condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- BMS-927711 (CGRP Antagonist)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2011to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Meet the diagnostic criteria for migraine with history of at least 1 year (with or without aura) at the screening visit
- Migraine attacks with the age of onset prior to 55 years old
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Community Research
Cincinnati, Ohio, 45255
California Clinical Trials Medical Group
Glendale, California, 91206
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806
Compass Research, Llc
Orlando, Florida, 32806
About this study
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
The purpose of this study is to evaluate the pharmacokinetics (PK) of BMS-927711 during migraine and non-migraine condition.
Read the detailed description
Study Classification: Safety CGRP = Calcitonin gene related peptide
- Conditions
- Migraine
- Being tested
- BMS-927711 (CGRP Antagonist)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-927711 (CGRP Antagonist)Drug
Capsule, Oral, 300 mg, Once, One day
BMS-927711 (CGRP Antagonist)Drug
Capsule, Oral, 600 mg, Once, One day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BMS-927711 (300 mg) | Active comparator | Not described Receives: Drug: BMS-927711 (CGRP Antagonist) |
| Arm 2: BMS-927711 (600 mg) | Active comparator | Not described Receives: Drug: BMS-927711 (CGRP Antagonist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of BMS-927711 will be derived from plasma concentration versus time
Measured: PK samples will be collected for up to 24 hours after the dosing
Time of maximum observed plasma concentration (Tmax) of BMS-927711 will be derived from plasma concentration versus time
Measured: PK samples will be collected for up to 24 hours after the dosing
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
Measured: PK samples will be collected for up to 24 hours after the dosing
Observed plasma concentration at 0.5 hr (C0.5h) of BMS-927711 will be derived from plasma concentration versus time
Measured: PK samples will be collected for up to 24 hours after the dosing
Observed plasma concentration at 2h (C2h) of BMS-927711 will be derived from plasma concentration versus time
Measured: PK samples will be collected for up to 24 hours after the dosing
Apparent total body clearance (CLT/F) of BMS-927711 will be derived from plasma concentration versus time
Measured: PK samples will be collected for up to 24 hours after the dosing
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax) will be derived from plasma concentration versus time
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
Measured: From Day 1 0 hour to Day 2 24 hour time points
Time of maximum observed plasma concentration (Tmax) will be derived from plasma concentration versus time
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
Measured: From Day 1 0 hour to Day 2 24 hour time points
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
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
Measured: From Day 1 0 hour to Day 2 24 hour time points
Observed plasma concentration at 0.5 hr (C0.5h) will be derived from plasma concentration versus time
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
Measured: From Day 1 0 hour to Day 2 24 hour time points
Observed plasma concentration at 2 hr (C2h) will be derived from plasma concentration versus time
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
Measured: From Day 1 0 hour to Day 2 24 hour time points
Apparent total body clearance (CLT/F) will be derived from plasma concentration versus time
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
Measured: From Day 1 0 hour to Day 2 24 hour time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445067
- Sponsor's protocol ID
- CN170-004
- Status last verified
- Dec 2022
- First submitted
- 30 Sep 2011
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01445067
- Acronym / sponsor ID
- CN170-004
- Conditions
- Migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics (PK) of BMS-927711 during migraine and non-migraine condition.
Detailed description
Study Classification: Safety CGRP = Calcitonin gene related peptide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BMS-927711 (300 mg) | Active comparator | Drug: BMS-927711 (CGRP Antagonist) |
| Arm 2: BMS-927711 (600 mg) | Active comparator | Drug: BMS-927711 (CGRP Antagonist) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-927711 (CGRP Antagonist)Capsule, Oral, 300 mg, Once, One day | Drug | Arm 1: BMS-927711 (300 mg) |
| BMS-927711 (CGRP Antagonist)Capsule, Oral, 600 mg, Once, One day | Drug | Arm 2: BMS-927711 (600 mg) |
Primary outcome
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
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
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
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
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
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-927711 (CGRP Antagonist) in people with Migraine, run by Pfizer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.