Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the pharmacokinetics (PK) of BMS-927711 during migraine and non-migraine condition.
Study Classification: Safety CGRP = Calcitonin gene related peptide
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-927711 (300 mg) | Active Comparator |
| |
| Arm 2: BMS-927711 (600 mg) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-927711 (CGRP Antagonist) | Drug | Capsule, Oral, 300 mg, Once, One day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-927711 will be derived from plasma concentration versus time | 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 | 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 | 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 | 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 | 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 | PK samples will be collected for up to 24 hours after the dosing |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Day 1 0 hour to Day 2 24 hour time points |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group | Glendale | California | 91206 | United States | ||
| Collaborative Neuroscience Network, Inc. |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BMS-927711 (CGRP Antagonist) |
| Drug |
Capsule, Oral, 600 mg, Once, One day |
|
| 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 |
| 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 | 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 | 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 | 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 | From Day 1 0 hour to Day 2 24 hour time points |
| Long Beach |
| California |
| 90806 |
| United States |
| Compass Research, Llc | Orlando | Florida | 32806 | United States |
| Community Research | Cincinnati | Ohio | 45255 | United States |
| D009422 | Nervous System Diseases |