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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04179474
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Actual Duration (Months): 2.9
• Patients Per Site: 20
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Ubrogepant; Drug: Erenumab; Drug: Galcanezumab	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1b, Two-Part, Open-Label, Fixed-Sequence, Safety, Tolerability and Drug-Drug Interaction Study Between Single Dose Erenumab or Galcanezumab and Multiple Dose Ubrogepant in Participants With Migraine
• Actual Study Start Date: Sep 26, 2019
• Actual Primary Completion Date: Dec 23, 2019
• Actual Study Completion Date: Dec 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	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].
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.	Drug: Ubrogepant; Oral administration of 100 mg ubrogepant tablet once daily [Intervention A=single dose and Intervention D=repeated daily dose].; Drug: Galcanezumab; 2 SC injections of galcanezumab 120 mg [Intervention C].

Outcome Measures

Primary Outcome Measures

1. 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 [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]

2. Part 2: AUC0-t for Ubrogepant Alone and in Combination With Galcanezumab [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]

3. Part 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC0-∞) for Ubrogepant Alone and in Combination With Erenumab [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]

4. Part 2: AUC0-∞ for Ubrogepant Alone and in Combination With Galcanezumab [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]

5. Part 1: Maximum Plasma Drug Concentration (Cmax) for Ubrogepant Alone in Combination With Erenumab [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]

6. Part 2: Cmax for Ubrogepant Alone and in Combination With Galcanezumab [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]

Secondary Outcome Measures

1. Part 1: Time of Maximum Plasma Drug Concentration (Tmax) for Ubrogepant Alone and in Combination With Erenumab [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]

2. Part 2: Tmax for Ubrogepant Alone and in Combination With Galcanezumab [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]

3. Part 1: Terminal Elimination Rate Constant (λz) for Ubrogepant Alone and in Combination With Erenumab [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]

4. Part 2: λz for Ubrogepant Alone and in Combination With Galcanezumab [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]

5. Part 1: Terminal Elimination Half-life (T½) for Ubrogepant Alone and in Combination With Erenumab [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]

6. Part 2: T½ for Ubrogepant Alone and in Combination With Galcanezumab [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]

7. Part 1: Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for Ubrogepant Alone and in Combination With Erenumab [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]

8. Part 2: CL/F for Ubrogepant Alone and in Combination With Galcanezumab [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]

9. Part 1: Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for Ubrogepant Alone in Combination With Erenumab [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]

10. Part 2: Vz/F for Ubrogepant Alone in Combination With Galcanezumab [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]

11. Number of Participants Who Had Potentially Clinically Significant (PCS) Postbaseline Vital Sign Values [End of Dosing (EOD): Within 7 days of Day 16 or at the time of early termination (Up to Day 16)]

    Vital Signs included assessments of Blood Pressure, Pulse Rate, Weight, Respiratory Rate and Temperature. The investigator determined if the postbaseline Vital Sign values were potentially clinically significant using the Vital Sign PCS Criteria in the Statistical Analysis Plan (SAP).

12. Number of Participants Who Had PCS Postbaseline Laboratory Values [EOD: Within 7 days of Day 16 or at the time of early termination (Up to Day 16); Follow-up Visit 30 days after last dose (Up to Day 45 +/-3 days)]

    Laboratory assessments included Chemistry, Hematology and Urinalysis tests. The investigator determined if the postbaseline laboratory results were potentially clinically significant using the Clinical Laboratory PCS Criteria in the SAP. Assessments of Chemistry only were collected at the Final Follow-up Visit

13. Number of Participants Who Had PCS Postbaseline Physical Examination Values [EOD: Within 7 days of Day 16 or at the time of early termination (Up to Day 16)]

14. Number of Participants Who Had PCS Postbaseline Electrocardiogram (ECG) Values [EOD: Within 7 days of Day 16 or at the time of early termination (Up to Day 16)]

    A standard 12-lead ECG was performed. The investigator determined if the ECG postbaseline values were potentially clinically significant using the ECG PCS Criteria in the SAP.

15. Number of Participants With Adverse Events (AEs) by Severity, Related AEs and AEs Leading to Discontinuation [First dose to within 30 days after last dose (Up to Day 45 +/-3 days)]

    An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The investigator determined if the AE was causally related to treatment. The investigator determined if the severity of the AE was Mild (transient with minimal intervention that does not interfere with usual activities), Moderate ( usually alleviated with an intervention, interferes with usual activities causing discomfort but does not cause permanent harm) or Severe (interrupts usual activities, affects clinical status or requires intensive intervention).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QPS	Springfield	Missouri	United States	65802
2	Spaulding	West Bend	Wisconsin	United States	53095

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Ramesh Boinpally, Allergan

Study Documents (Full-Text)

• Statistical Analysis Plan - Mar 18, 2020
• Study Protocol - Aug 14, 2019

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT04179474
• Other Study ID Numbers: 3110-108-002
• First Posted: Nov 27, 2019
• Last Update Posted: Mar 10, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Allergan: ubrogepant; erenumab; galcanezumab; safety; tolerability; interaction
• Additional relevant MeSH terms: Migraine Disorders; Erenumab

Study Results

Participant Flow

Arm/Group Title	Part 1 (Intervention A Then B Then D)	Part 2 (Intervention A Then C Then D)
Arm/Group Description	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.	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.
Period Title: Treatment Period 1 (First Intervention)
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0
Period Title: Treatment Period 1 (First Intervention)
STARTED	19	20
COMPLETED	19	20
NOT COMPLETED	0	0
Period Title: Treatment Period 1 (First Intervention)
STARTED	19	19
COMPLETED	19	19
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Part 1 (Intervention A Then B Then D)	Part 2 (Intervention A Then C Then D)	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	20	20	40
Age, Customized (years) [Mean (Full Range) ]
Mean (Full Range) [years]	32.2	38.4	35.3
Sex: Female, Male (Count of Participants)
Female	10 50%	12 60%	22 55%
Male	10 50%	8 40%	18 45%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	4 20%	4 10%
Not Hispanic or Latino	20 100%	16 80%	36 90%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 35%	9 45%	16 40%
White	12 60%	11 55%	23 57.5%
More than one race	1 5%	0 0%	1 2.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
North America	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Pharmacokinetic 1 (PK1) population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 1: Ubrogepant Alone	Part 1: Ubrogepant in Combination With Erenumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.	Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [nanogram*hour/milliliter (ng*h/mL)]	1841.42 (490.17)	1959.96 (639.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: Ubrogepant Alone, Part 1: Ubrogepant in Combination With Erenumab
	Comments	A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.
	Type of Statistical Test	Equivalence
	Comments	"No effect" of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometric Mean Percentage
	Estimated Value	105.55
	Confidence Interval	(2-Sided) 90%; 96.21 to 115.79
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone * 100

2. Primary Outcome

Title	Part 2: AUC0-t for Ubrogepant Alone and in Combination With Galcanezumab
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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab

Arm/Group Title	Part 2: Ubrogepant Alone	Part 2: Ubrogepant in Combination With Galcanezumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.	Participants received Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [ng*h/mL]	1700.31 (913.42)	1758.05 (1033.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: Ubrogepant Alone, Part 1: Ubrogepant in Combination With Erenumab
	Comments	A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.
	Type of Statistical Test	Equivalence
	Comments	"No effect" of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometric Mean Percentage
	Estimated Value	105.03
	Confidence Interval	(2-Sided) 90%; 89.55 to 123.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone * 100

3. Primary Outcome

Title	Part 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC0-∞) 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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 1: Ubrogepant Alone	Part 1: Ubrogepant in Combination With Erenumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.	Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [ng*h/mL]	1878.25 (497.82)	1993.40 (639.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: Ubrogepant Alone, Part 1: Ubrogepant in Combination With Erenumab
	Comments	A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.
	Type of Statistical Test	Equivalence
	Comments	"No effect" of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometric Mean Percentage
	Estimated Value	105.38
	Confidence Interval	(2-Sided) 90%; 96.19 to 115.45
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone * 100

4. Primary Outcome

Title	Part 2: AUC0-∞ for Ubrogepant Alone and in Combination With Galcanezumab
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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 2: Ubrogepant Alone	Part 2: Ubrogepant in Combination With Galcanezumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.	Participants received Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [ng*h/mL]	1732.22 (928.06)	1793.74 (1057.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: Ubrogepant Alone, Part 1: Ubrogepant in Combination With Erenumab
	Comments	A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.
	Type of Statistical Test	Equivalence
	Comments	"No effect" of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometric Mean Percentage
	Estimated Value	104.76
	Confidence Interval	(2-Sided) 90%; 89.68 to 122.38
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone * 100

5. Primary Outcome

Title	Part 1: Maximum Plasma Drug Concentration (Cmax) for Ubrogepant Alone 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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 1: Ubrogepant Alone	Part 1: Ubrogepant in Combination With Erenumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.	Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [ng/mL]	459.32 (168.56)	486.80 (201.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: Ubrogepant Alone, Part 1: Ubrogepant in Combination With Erenumab
	Comments	A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means
	Type of Statistical Test	Equivalence
	Comments	"No effect" of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometric Mean Percentage
	Estimated Value	103.86
	Confidence Interval	(2-Sided) 90%; 93.01 to 115.98
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone * 100

6. Primary Outcome

Title	Part 2: Cmax for Ubrogepant Alone and in Combination With Galcanezumab
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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 2: Ubrogepant Alone	Part 2: Ubrogepant in Combination With Galcanezumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.	Participants received Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [ng/mL]	415.34 (225.64)	375.12 (152.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: Ubrogepant Alone, Part 1: Ubrogepant in Combination With Erenumab
	Comments	A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.
	Type of Statistical Test	Equivalence
	Comments	"No effect" of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Geometric Mean Percentage
	Estimated Value	99.55
	Confidence Interval	(2-Sided) 90%; 82.27 to 120.45
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone * 100

7. Secondary Outcome

Title	Part 1: Time of Maximum Plasma Drug Concentration (Tmax) 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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 1: Ubrogepant Alone	Part 1: Ubrogepant in Combination With Erenumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.	Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Median (Full Range) [hour]	1.50	1.48

8. Secondary Outcome

Title	Part 2: Tmax for Ubrogepant Alone and in Combination With Galcanezumab
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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 2: Ubrogepant Alone	Part 2: Ubrogepant in Combination With Galcanezumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.	Participants received Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Median (Full Range) [hour]	1.50	1.50

9. Secondary Outcome

Title	Part 1: Terminal Elimination Rate Constant (λz) 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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 1: Ubrogepant Alone	Part 1: Ubrogepant in Combination With Erenumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.	Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [1/hour]	0.136 (0.025)	0.156 (0.034)

10. Secondary Outcome

Title	Part 2: λz for Ubrogepant Alone and in Combination With Galcanezumab
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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 2: Ubrogepant Alone	Part 2: Ubrogepant in Combination With Galcanezumab
Arm/Group Description	Participant received Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasting conditions.	Participants received Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [1/hour]	0.150 (0.053)	0.165 (0.056)

11. Secondary Outcome

Title	Part 1: Terminal Elimination Half-life (T½) 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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 1: Ubrogepant Alone	Part 1: Ubrogepant in Combination With Erenumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.	Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [hour]	5.26 (1.00)	4.62 (0.94)

12. Secondary Outcome

Title	Part 2: T½ for Ubrogepant Alone and in Combination With Galcanezumab
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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 2: Ubrogepant Alone	Part 2: Ubrogepant in Combination With Galcanezumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.	Participants received Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [hour]	5.04 (1.47)	4.60 (1.35)

13. Secondary Outcome

Title	Part 1: Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) 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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 1: Ubrogepant Alone	Part 1: Ubrogepant in Combination With Erenumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.	Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [liter/hour]	57.35 (17.20)	54.74 (16.27)

14. Secondary Outcome

Title	Part 2: CL/F for Ubrogepant Alone and in Combination With Galcanezumab
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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 2: Ubrogepant Alone	Part 2: Ubrogepant in Combination With Galcanezumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.	Participants received Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [liter/hour]	72.90 (38.07)	68.94 (28.12)

15. Secondary Outcome

Title	Part 1: Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for Ubrogepant Alone 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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 1: Ubrogepant Alone	Part 1: Ubrogepant in Combination With Erenumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.	Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [liter]	436.95 (158.11)	375.84 (161.42)

16. Secondary Outcome

Title	Part 2: Vz/F for Ubrogepant Alone in Combination With Galcanezumab
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

Outcome Measure Data

Analysis Population Description

PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.

Arm/Group Title	Part 2: Ubrogepant Alone	Part 2: Ubrogepant in Combination With Galcanezumab
Arm/Group Description	Participants received Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.	Participants received Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
Measure Participants	20	19
Mean (Standard Deviation) [liter]	568.66 (497.92)	449.26 (213.84)

17. Secondary Outcome

Title	Number of Participants Who Had Potentially Clinically Significant (PCS) Postbaseline Vital Sign Values
Description	Vital Signs included assessments of Blood Pressure, Pulse Rate, Weight, Respiratory Rate and Temperature. The investigator determined if the postbaseline Vital Sign values were potentially clinically significant using the Vital Sign PCS Criteria in the Statistical Analysis Plan (SAP).
Time Frame	End of Dosing (EOD): Within 7 days of Day 16 or at the time of early termination (Up to Day 16)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received/took at least 1 administration of study intervention in Part 1 or Part 2.

Arm/Group Title	Part 1 (Intervention A Then B Then D)	Part 2 (Intervention A Then C Then D)
Arm/Group Description	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.	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.
Measure Participants	20	20
Count of Participants [Participants]	0 0%	0 0%

18. Secondary Outcome

Title	Number of Participants Who Had PCS Postbaseline Laboratory Values
Description	Laboratory assessments included Chemistry, Hematology and Urinalysis tests. The investigator determined if the postbaseline laboratory results were potentially clinically significant using the Clinical Laboratory PCS Criteria in the SAP. Assessments of Chemistry only were collected at the Final Follow-up Visit
Time Frame	EOD: Within 7 days of Day 16 or at the time of early termination (Up to Day 16); Follow-up Visit 30 days after last dose (Up to Day 45 +/-3 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received/took at least 1 administration of study intervention in Part 1 or Part 2.

Arm/Group Title	Part 1 (Intervention A Then B Then D)	Part 2 (Intervention A Then C Then D)
Arm/Group Description	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.	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.
Measure Participants	20	20
Hematology; EOD	0 0%	1 5%
Chemistry; EOD	0 0%	0 0%
Chemistry; Follow-up Visit	1 5%	1 5%
Urinalysis; EOD	1 5%	0 0%

19. Secondary Outcome

Title	Number of Participants Who Had PCS Postbaseline Physical Examination Values
Time Frame	EOD: Within 7 days of Day 16 or at the time of early termination (Up to Day 16)

Outcome Measure Data

Analysis Population Description

As per the SAP, abnormalities in physical examinations during the study were captured in medical history or Adverse Events (AEs) data panels. Therefore, there were no separate analyses for physical examination planned.

Arm/Group Title	Part 1 (Intervention A Then B Then D)	Part 2 (Intervention A Then C Then D)
Arm/Group Description	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.	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.
Measure Participants	0	0

20. Secondary Outcome

Title	Number of Participants Who Had PCS Postbaseline Electrocardiogram (ECG) Values
Description	A standard 12-lead ECG was performed. The investigator determined if the ECG postbaseline values were potentially clinically significant using the ECG PCS Criteria in the SAP.
Time Frame	EOD: Within 7 days of Day 16 or at the time of early termination (Up to Day 16)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received/took at least 1 administration of study intervention in Part 1 or Part 2.

Arm/Group Title	Part 1 (Intervention A Then B Then D)	Part 2 (Intervention A Then C Then D)
Arm/Group Description	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.	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.
Measure Participants	20	20
Count of Participants [Participants]	0 0%	0 0%

21. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs) by Severity, Related AEs and AEs Leading to Discontinuation
Description	An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The investigator determined if the AE was causally related to treatment. The investigator determined if the severity of the AE was Mild (transient with minimal intervention that does not interfere with usual activities), Moderate ( usually alleviated with an intervention, interferes with usual activities causing discomfort but does not cause permanent harm) or Severe (interrupts usual activities, affects clinical status or requires intensive intervention).
Time Frame	First dose to within 30 days after last dose (Up to Day 45 +/-3 days)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received/took at least 1 administration of study intervention. Data is reported by intervention actually received.

Arm/Group Title	Part 1: Intervention A (Ubrogepant)	Part 1: Intervention B (Erenumab)	Part 1: Intervention D (Ubrogepant)	Part 2: Intervention A (Ubrogepant)	Part 2: Intervention C (Galcanezumab)	Part 2: Intervention D (Ubrogepant)
Arm/Group Description	Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.	Intervention B (erenumab 140 mg) single SC injection on Day 8.	Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.	Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.	Intervention C (galcanezumab 120 mg) two SC injections on Day 8.	Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
Measure Participants	20	19	19	20	20	19
All AEs	7 35%	8 40%	7 17.5%	2 NaN	3 NaN	4 NaN
AEs by Severity: Mild	7 35%	8 40%	6 15%	2 NaN	3 NaN	4 NaN
AEs by Severity: Moderate	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
AEs by Severity: Severe	0 0%	0 0%	1 2.5%	0 NaN	0 NaN	0 NaN
Related AEs	2 10%	7 35%	5 12.5%	0 NaN	3 NaN	3 NaN
AEs Leading to Discontinuation	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN

Adverse Events

Time Frame	First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Adverse Event Reporting Description	Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
Arm/Group Title	Part 1: Intervention A (Ubrogepant)		Part 1: Intervention B (Erenumab)		Part 1: Intervention D (Ubrogepant)		Part 2; Intervention A (Ubrogepant)		Part 2: Intervention C (Galcanezumab)		Part 2: Intervention D (Ubrogepant)
Arm/Group Description	Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.		Intervention B (erenumab 140 mg) single SC injection on Day 8.		Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.		Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.		Intervention C (galcanezumab 120 mg) two SC injections on Day 8.		Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
All Cause Mortality
	Part 1: Intervention A (Ubrogepant)		Part 1: Intervention B (Erenumab)		Part 1: Intervention D (Ubrogepant)		Part 2; Intervention A (Ubrogepant)		Part 2: Intervention C (Galcanezumab)		Part 2: Intervention D (Ubrogepant)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)		0/19 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)
Serious Adverse Events
	Part 1: Intervention A (Ubrogepant)		Part 1: Intervention B (Erenumab)		Part 1: Intervention D (Ubrogepant)		Part 2; Intervention A (Ubrogepant)		Part 2: Intervention C (Galcanezumab)		Part 2: Intervention D (Ubrogepant)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)		0/19 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Part 1: Intervention A (Ubrogepant)		Part 1: Intervention B (Erenumab)		Part 1: Intervention D (Ubrogepant)		Part 2; Intervention A (Ubrogepant)		Part 2: Intervention C (Galcanezumab)		Part 2: Intervention D (Ubrogepant)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/20 (35%)		8/19 (42.1%)		7/19 (36.8%)		2/20 (10%)		3/20 (15%)		4/19 (21.1%)
Gastrointestinal disorders
Constipation	0/20 (0%)		1/19 (5.3%)		2/19 (10.5%)		0/20 (0%)		0/20 (0%)		0/19 (0%)
Flatulence	0/20 (0%)		1/19 (5.3%)		0/19 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)
Abdominal pain upper	0/20 (0%)		0/19 (0%)		2/19 (10.5%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)
Nausea	0/20 (0%)		0/19 (0%)		2/19 (10.5%)		0/20 (0%)		0/20 (0%)		0/19 (0%)
Abdominal pain	0/20 (0%)		0/19 (0%)		1/19 (5.3%)		0/20 (0%)		0/20 (0%)		0/19 (0%)
Vomiting	0/20 (0%)		0/19 (0%)		1/19 (5.3%)		1/20 (5%)		0/20 (0%)		0/19 (0%)
Abdominal discomfort	0/20 (0%)		0/19 (0%)		0/19 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)
General disorders
Puncture site pain	3/20 (15%)		0/19 (0%)		0/19 (0%)		2/20 (10%)		0/20 (0%)		0/19 (0%)
Infections and infestations
Nasopharyngitis	1/20 (5%)		0/19 (0%)		0/19 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)
Injury, poisoning and procedural complications
Post lumbar puncture syndrome	1/20 (5%)		0/19 (0%)		0/19 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)
Musculoskeletal and connective tissue disorders
Neck pain	1/20 (5%)		0/19 (0%)		0/19 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)
Musculoskeletal pain	0/20 (0%)		1/19 (5.3%)		0/19 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)
Nervous system disorders
Headache	2/20 (10%)		6/19 (31.6%)		1/19 (5.3%)		0/20 (0%)		3/20 (15%)		0/19 (0%)
Somnolence	1/20 (5%)		0/19 (0%)		0/19 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)
Dizziness	0/20 (0%)		0/19 (0%)		1/19 (5.3%)		0/20 (0%)		0/20 (0%)		2/19 (10.5%)
Neuropathy peripheral	0/20 (0%)		0/19 (0%)		0/19 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)
Respiratory, thoracic and mediastinal disorders
Hiccups	0/20 (0%)		1/19 (5.3%)		0/19 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)
Skin and subcutaneous tissue disorders
Dermatitis contact	0/20 (0%)		1/19 (5.3%)		0/19 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.