Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Ubrogepant; Erenumab; Galcanezumab
Intervention description: Oral administration of 100 mg ubrogepant tablet once daily [Intervention A=single dose and Intervention D=repeated daily dose].; Single dose subcutaneous (SC) injection of erenumab 140 mg [Intervention B].; 2 SC injections of galcanezumab 120 mg [Intervention C].
Intervention MeSH terms: Erenumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: ubrogepant; erenumab; galcanezumab; safety; tolerability; interaction

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis
             according to the International Classification of Headache Disorders, 3rd edition,
             (ICHD-3, 2018)

          -  By history, the participant's migraines typically last between 4 and 72 hours if
             untreated or treated unsuccessfully and migraine episodes are separated by at least 48
             hours of headache pain freedom

          -  History of at least 2 migraine attacks per month in the 2 months prior to Screening

          -  Have a sitting pulse rate ≥ 45 beats per minute (bpm) and ≤ 100 bpm during the vital
             sign assessment at the Screening Visit. Clinical site may perform a maximum of 2
             repeats of vital sign measurements if the initial measurement is out of range.

          -  Negative test results for benzoylecgonine (cocaine), methadone, barbiturates,
             amphetamines, benzodiazepines, cannabinoids, opiates, and phencyclidine at the
             Screening Visit and Day -1; unless explained by concomitant medication use (eg,
             opioids prescribed for migraine pain)

          -  Participants willing to minimize the risk of inducing pregnancy for the duration of
             the clinical study and follow-up period

        Exclusion Criteria:

          -  Difficulty distinguishing migraine headache from tension-type or other headaches

          -  Has a history of migraine aura with diplopia or impairment of level of consciousness,
             hemiplegic migraine, or retinal migraine as defined by ICHD-3

          -  Has a current diagnosis of new persistent daily headache, trigeminal autonomic
             cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3

          -  Required hospital treatment of a migraine attack 3 or more times in the 6 months prior
             to Screening

          -  Has a chronic non-headache pain condition requiring daily pain medication (with the
             exception of pregabalin)

          -  Has clinically significant cardiovascular or cerebrovascular disease per the
             investigator's opinion

          -  Previously participated in an investigational study of ubrogepant

          -  Participation in any other clinical investigation using an experimental drug within 30
             days prior to study intervention administration

          -  Participation in a blood or plasma donation program within 60 or 30 days,
             respectively, prior to study intervention administration