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This study will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ubrogepant-Part 1-Dose A | Experimental | Participants will receive a single oral dose A of ubrogepant on Day 1 under fasting conditions. |
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| Ubrogepant-Part 1-Dose B | Experimental | Participants will receive a single oral dose B of ubrogepant on Day 1 under fasting conditions. |
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| Ubrogepant-Part 2-Dose C | Experimental | Participants will receive a single oral dose C of ubrogepant on Day 1 under fasting conditions. |
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| Ubrogepant-Part 2-Dose D | Experimental | Participants will receive a single oral dose D of ubrogepant on Day 1 under fed conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubrogepant | Drug | IRT Oral Tablet |
| |
| Ubrogepant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to approximately 33 days |
| Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of Ubrogepant | AUCt of Ubrogepant | Up to approximately 3 days |
| AUC From Time 0 to the Time Infinity (AUCinf) of Ubrogepant | AUCinf of Ubrogepant | Up to approximately 3 days |
| Maximum Observed Plasma Concentration (Cmax) of Ubrogepant | Cmax of Ubrogepant | Up to approximately 3 days |
| Time lag between dosing and drug to appear in systemic circulation following extravascular administration (Tlag) of Ubrogepant | Tlag of Ubrogepant | Up to approximately 3 days |
| Time to maximum observed plasma concentration (Tmax) of Ubrogepant | Tmax of Ubrogepant | Up to approximately 3 days |
| Apparent terminal phase elimination constant (λz) of Ubrogepant | λz of Ubrogepant | Up to approximately 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
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| ID | Term |
|---|---|
| C000615620 | ubrogepant |
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| Drug |
ODT Oral Tablet |
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| Terminal phase elimination half-life (t1/2) of Ubrogepant | t1/2 of Ubrogepant | Up to approximately 3 days |
| Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Ubrogepant | CL/F of Ubrogepant | Up to approximately 3 days |
| Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Ubrogepant | Vz/F of Ubrogepant | Up to approximately 3 days |