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

NCT ID: NCT04179474

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2019-12-23

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ubrogepant

Intervention Type: DRUG

Oral administration of 100 mg ubrogepant tablet once daily \[Intervention A=single dose and Intervention D=repeated daily dose\].

Erenumab

Intervention Type: DRUG

Single dose subcutaneous (SC) injection of erenumab 140 mg \[Intervention B\].

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.

Group Type: EXPERIMENTAL

Ubrogepant

Intervention Type: DRUG

Oral administration of 100 mg ubrogepant tablet once daily \[Intervention A=single dose and Intervention D=repeated daily dose\].

Galcanezumab

Intervention Type: DRUG

2 SC injections of galcanezumab 120 mg \[Intervention C\].

Interventions

Ubrogepant

Oral administration of 100 mg ubrogepant tablet once daily \[Intervention A=single dose and Intervention D=repeated daily dose\].

Intervention Type: DRUG

Erenumab

Single dose subcutaneous (SC) injection of erenumab 140 mg \[Intervention B\].

Intervention Type: DRUG

Galcanezumab

2 SC injections of galcanezumab 120 mg \[Intervention C\].

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramesh Boinpally

Role: STUDY_DIRECTOR

Allergan

Locations

QPS

Springfield, Missouri, United States

Spaulding

West Bend, Wisconsin, United States

Countries

United States

References

Jakate A,Boinpally R, Butler M, Borbridge L, Contreras-De Lama J, McGeeney D, Periclou A. Safety and tolerability of ubrogepant for the acute treatment of migraine following co-administration with preventive monoclonal antibody treatment [abstract]. In:62nd Annual Scientific Meeting American Headache Society; June2020; San Diego, California.

Reference Type: RESULT

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

3110-108-002

Identifier Type: -

Identifier Source: org_study_id