Phase 1
Completed N=40
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
Source: ClinicalTrials.gov NCT04179474 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: 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 — 1841.42; 1959.96 nanogram*hour/milliliter (ng*h/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
1841.42; 1959.96 | — |
| PRIMARY Part 2: AUC0-t for Ubrogepant Alone and in Combination With Galcanezumab |
1700.31; 1758.05 | — |
| 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 |
1878.25; 1993.40 | — |
| PRIMARY Part 2: AUC0-∞ for Ubrogepant Alone and in Combination With Galcanezumab |
1732.22; 1793.74 | — |
| PRIMARY Part 1: Maximum Plasma Drug Concentration (Cmax) for Ubrogepant Alone in Combination With Erenumab |
459.32; 486.80 | — |
| PRIMARY Part 2: Cmax for Ubrogepant Alone and in Combination With Galcanezumab |
415.34; 375.12 | — |
| SECONDARY Part 1: Time of Maximum Plasma Drug Concentration (Tmax) for Ubrogepant Alone and in Combination With Erenumab |
1.50; 1.48 | — |
| SECONDARY Part 2: Tmax for Ubrogepant Alone and in Combination With Galcanezumab |
1.50; 1.50 | — |
| SECONDARY Part 1: Terminal Elimination Rate Constant (λz) for Ubrogepant Alone and in Combination With Erenumab |
0.136; 0.156 | — |
| SECONDARY Part 2: λz for Ubrogepant Alone and in Combination With Galcanezumab |
0.150; 0.165 | — |
| SECONDARY Part 1: Terminal Elimination Half-life (T½) for Ubrogepant Alone and in Combination With Erenumab |
5.26; 4.62 | — |
| SECONDARY Part 2: T½ for Ubrogepant Alone and in Combination With Galcanezumab |
5.04; 4.60 | — |
| SECONDARY Part 1: Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for Ubrogepant Alone and in Combination With Erenumab |
57.35; 54.74 | — |
| SECONDARY Part 2: CL/F for Ubrogepant Alone and in Combination With Galcanezumab |
72.90; 68.94 | — |
| SECONDARY Part 1: Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for Ubrogepant Alone in Combination With Erenumab |
436.95; 375.84 | — |
| SECONDARY Part 2: Vz/F for Ubrogepant Alone in Combination With Galcanezumab |
568.66; 449.26 | — |
| SECONDARY Number of Participants Who Had Potentially Clinically Significant (PCS) Postbaseline Vital Sign Values |
0; 0 | — |
| SECONDARY Number of Participants Who Had PCS Postbaseline Laboratory Values |
0; 1; 0; 0; 1; 1 | — |
| SECONDARY Number of Participants Who Had PCS Postbaseline Physical Examination Values |
— | — |
| SECONDARY Number of Participants Who Had PCS Postbaseline Electrocardiogram (ECG) Values |
0; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) by Severity, Related AEs and AEs Leading to Discontinuation |
7; 8; 7; 2; 3; 4 | — |
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
Data sourced from ClinicalTrials.gov (NCT04179474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.