NCT04179474

Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Ubrogepant	Oral administration of 100 mg ubrogepant tablet once daily \[Intervention A=single dose and Intervention D=repeated daily dose\].
DRUG	Erenumab	Single dose subcutaneous (SC) injection of erenumab 140 mg \[Intervention B\].
DRUG	Galcanezumab	2 SC injections of galcanezumab 120 mg \[Intervention C\].

Timeline

• Start date: 2019-09-26
• Primary completion: 2019-12-23
• Completion: 2019-12-23
• First posted: 2019-11-27
• Last updated: 2021-03-10
• Results posted: 2021-03-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study