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

Part of paid clinical trials in Springfield, Missouri.

Sponsor
Allergan
Study ID
NCT04179474
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 26, 2019
Status verified
Feb 2021
Primary completion
Dec 23, 2019
Completion
Dec 23, 2019

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1 (Intervention A then B then D)
    Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention B: Single subcutaneous (SC) injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
  • Experimental: Part 2 (Intervention A then C then D)
    Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.

Primary Outcome Measure

Part 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time t (AUC0-t) for Ubrogepant Alone and in Combination With Erenumab [ Time Frame: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose ]

Locations (2)

FacilityCityStateZIPSite coordinators
QPSSpringfieldMissouri65802-
SpauldingWest BendWisconsin53095-

Find similar trials in Springfield, MO

By condition
Migraine
By specialty
Neurology
By research site
QPS· Springfield, MOSpaulding· West Bend, WI

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