Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
NCT04179474 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2021-03-10
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
Interventions
- 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 \[Intervention C\].
Sponsors & Collaborators
-
Allergan
lead INDUSTRY
Principal Investigators
-
Ramesh Boinpally · Allergan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-26
- Primary Completion
- 2019-12-23
- Completion
- 2019-12-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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