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

• Status: Completed
• Trial end date: 2019-12-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Antibodies, Monoclonal; Erenumab

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