Trial · NCT04179474
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
NCT04179474, Phase 1, Completed, Allergan; results first posted 2021-03-10
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine. Trials, record NCT04179474. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04179474
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
- NCT number
- NCT04179474
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 40 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Migraine
- Interventions
- Ubrogepant, Erenumab, Galcanezumab
- First posted
- 2019-11-27
- Last updated
- 2021-03-10
- Results first posted
- 2021-03-10
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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. | nanogram*hour/milliliter (ng*h/mL) | MEAN |
| PRIMARY | 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 | 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 | ng*h/mL | MEAN |
| PRIMARY | 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 | 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. | ng*h/mL | MEAN |
| PRIMARY | 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 | 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. | ng*h/mL | MEAN |
| PRIMARY | 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 | 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. | ng/mL | MEAN |
| PRIMARY | 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 | 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. | ng/mL | MEAN |
| SECONDARY | 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 | 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. | hour | MEDIAN |
| SECONDARY | 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 | 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. | hour | MEDIAN |
| SECONDARY | 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 | 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. | 1/hour | MEAN |
| SECONDARY | 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 | 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. | 1/hour | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Part 1: Ubrogepant Alone | 1841.42 | Standard Deviation 490.17 | nanogram*hour/milliliter (ng*h/mL) | |
| 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 | Part 1: Ubrogepant in Combination With Erenumab | 1959.96 | Standard Deviation 639.51 | nanogram*hour/milliliter (ng*h/mL) | |
| Part 2: AUC0-t for Ubrogepant Alone and in Combination With Galcanezumab | Part 2: Ubrogepant Alone | 1700.31 | Standard Deviation 913.42 | ng*h/mL | |
| Part 2: AUC0-t for Ubrogepant Alone and in Combination With Galcanezumab | Part 2: Ubrogepant in Combination With Galcanezumab | 1758.05 | Standard Deviation 1033.44 | ng*h/mL | |
| Part 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC0-∞) for Ubrogepant Alone and in Combination With Erenumab | Part 1: Ubrogepant Alone | 1878.25 | Standard Deviation 497.82 | ng*h/mL | |
| Part 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC0-∞) for Ubrogepant Alone and in Combination With Erenumab | Part 1: Ubrogepant in Combination With Erenumab | 1993.40 | Standard Deviation 639.22 | ng*h/mL | |
| Part 2: AUC0-∞ for Ubrogepant Alone and in Combination With Galcanezumab | Part 2: Ubrogepant Alone | 1732.22 | Standard Deviation 928.06 | ng*h/mL | |
| Part 2: AUC0-∞ for Ubrogepant Alone and in Combination With Galcanezumab | Part 2: Ubrogepant in Combination With Galcanezumab | 1793.74 | Standard Deviation 1057.02 | ng*h/mL | |
| Part 1: Maximum Plasma Drug Concentration (Cmax) for Ubrogepant Alone in Combination With Erenumab | Part 1: Ubrogepant Alone | 459.32 | Standard Deviation 168.56 | ng/mL | |
| Part 1: Maximum Plasma Drug Concentration (Cmax) for Ubrogepant Alone in Combination With Erenumab | Part 1: Ubrogepant in Combination With Erenumab | 486.80 | Standard Deviation 201.52 | ng/mL |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (First Intervention) | STARTED | Part 1 (Intervention A Then B Then D) | 20 | |
| Treatment Period 1 (First Intervention) | STARTED | Part 2 (Intervention A Then C Then D) | 20 | |
| Treatment Period 1 (First Intervention) | COMPLETED | Part 1 (Intervention A Then B Then D) | 20 | |
| Treatment Period 1 (First Intervention) | COMPLETED | Part 2 (Intervention A Then C Then D) | 20 | |
| Treatment Period 1 (First Intervention) | NOT COMPLETED | Part 1 (Intervention A Then B Then D) | 0 | |
| Treatment Period 1 (First Intervention) | NOT COMPLETED | Part 2 (Intervention A Then C Then D) | 0 | |
| Treatment Period 2 (Second Intervention) | STARTED | Part 1 (Intervention A Then B Then D) | 19 | |
| Treatment Period 2 (Second Intervention) | STARTED | Part 2 (Intervention A Then C Then D) | 20 | |
| Treatment Period 2 (Second Intervention) | COMPLETED | Part 1 (Intervention A Then B Then D) | 19 | |
| Treatment Period 2 (Second Intervention) | COMPLETED | Part 2 (Intervention A Then C Then D) | 20 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events108
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Part 1: Intervention A (Ubrogepant) | 0 | 20 | |
| other | Constipation | Gastrointestinal disorders | Part 1: Intervention B (Erenumab) | 1 | 19 | |
| other | Constipation | Gastrointestinal disorders | Part 1: Intervention D (Ubrogepant) | 2 | 19 | |
| other | Constipation | Gastrointestinal disorders | Part 2; Intervention A (Ubrogepant) | 0 | 20 | |
| other | Constipation | Gastrointestinal disorders | Part 2: Intervention C (Galcanezumab) | 0 | 20 | |
| other | Constipation | Gastrointestinal disorders | Part 2: Intervention D (Ubrogepant) | 0 | 19 | |
| other | Flatulence | Gastrointestinal disorders | Part 1: Intervention A (Ubrogepant) | 0 | 20 | |
| other | Flatulence | Gastrointestinal disorders | Part 1: Intervention B (Erenumab) | 1 | 19 | |
| other | Flatulence | Gastrointestinal disorders | Part 1: Intervention D (Ubrogepant) | 0 | 19 | |
| other | Flatulence | Gastrointestinal disorders | Part 2; Intervention A (Ubrogepant) | 0 | 20 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Intervention A (Ubrogepant) | 0 | 20 |
| Total, all-cause mortality | Part 1: Intervention B (Erenumab) | 0 | 19 |
| Total, all-cause mortality | Part 1: Intervention D (Ubrogepant) | 0 | 19 |
| Total, all-cause mortality | Part 2; Intervention A (Ubrogepant) | 0 | 20 |
| Total, all-cause mortality | Part 2: Intervention C (Galcanezumab) | 0 | 20 |
| Total, all-cause mortality | Part 2: Intervention D (Ubrogepant) | 0 | 19 |
| Total, other adverse events | Part 1: Intervention A (Ubrogepant) | 7 | 20 |
| Total, other adverse events | Part 1: Intervention B (Erenumab) | 8 | 19 |
| Total, other adverse events | Part 1: Intervention D (Ubrogepant) | 7 | 19 |
| Total, other adverse events | Part 2; Intervention A (Ubrogepant) | 2 | 20 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42012062 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part 1 (Intervention A Then B Then D) vs Part 2 (Intervention A Then C Then D): Number of Participants Who Had PCS Postbaseline Electrocardiogram (ECG) Values | Trial comparisons |
| Part 1 (Intervention A Then B Then D) vs Part 2 (Intervention A Then C Then D): Number of Participants Who Had Potentially Clinically Significant (PCS) Postbaseline Vital Sign Values | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT04179474/registered?page=2