Study to Assess How Different Oral Formulations of Ubrogepant Move Through the Body in Healthy Adult Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAbbVie

About this trial

This study will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.

A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Disqualifiers

History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, neurologic, or psychiatric disease or disorder, history of Raynaud's Phenomenon, or any uncontrolled medical illness.

History of any clinically significant sensitivity or allergy to any medication or food.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Ubrogepant

    Drug

    IRT Oral Tablet

  • Ubrogepant

    Drug

    ODT Oral Tablet

Treatment groups

52 Participants
are divided into 4 treatment groups
Group A: Ubrogepant-Part 1-Dose AExperimental treatment 1 intervention
Group B: Ubrogepant-Part 1-Dose BExperimental treatment 1 intervention
Group C: Ubrogepant-Part 2-Dose CExperimental treatment 1 intervention
Group D: Ubrogepant-Part 2-Dose DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to approximately 33 days
2

Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of Ubrogepant

AUCt of Ubrogepant

Time frame
Up to approximately 3 days
3

AUC From Time 0 to the Time Infinity (AUCinf) of Ubrogepant

AUCinf of Ubrogepant

Time frame
Up to approximately 3 days
4

Maximum Observed Plasma Concentration (Cmax) of Ubrogepant

Cmax of Ubrogepant

Time frame
Up to approximately 3 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: