At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Ubrogepant +2 moredrug
Likely dose
Ubrogepant 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, Two-Part, Open-Label, Fixed-Sequence, Safety, Tolerability and Drug-Drug Interaction Study Between Single Dose Erenumab or Galcanezumab and Multiple Dose Ubrogepant in Participants With Migraine
In Brief
A Phase 1 clinical trial evaluating Ubrogepant, Erenumab, and 1 other intervention for Migraine. Completed, enrolled 40 participants across 2 sites.
Detailed Summary
This study will evaluate the potential for a pharmacokinetic (PK) interaction and provide safety and tolerability information when ubrogepant and erenumab or ubrogepant and galcanezumab are co-administered.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartSep 2019
First PostedNov 2019
Primary CompletionDec 2019
TodayJul 2026
First PostedNov 27, 2019
Enrollment StartSep 26, 2019
Primary CompletionDec 23, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.6 years ago
Interventions
Ubrogepantdrug
Oral administration of 100 mg ubrogepant tablet once daily \[Intervention A=single dose and Intervention D=repeated daily dose\].
Erenumabdrug
Single dose subcutaneous (SC) injection of erenumab 140 mg \[Intervention B\].
Galcanezumabdrug
2 SC injections of galcanezumab 120 mg \[Intervention C\].