Ubrogepant (MK-1602) is a novel, oral, calcitonin gene-related peptide receptor 
antagonist in clinical development with positive phase III outcomes for acute 
treatment of migraine. This paper describes the population exposure-response 
(E-R) modeling and simulations, which were used to inform the phase III 
dose-selection rationale, based on ~ 800 participants pooled across two phase 
IIb randomized dose-finding clinical trials. The E-R model describes the placebo 
and ubrogepant treatment effects based on migraine pain end points (2-hour pain 
relief and 2-hour pain freedom) at various dose levels. Sensitivity analyses 
were conducted to evaluate various assumptions of placebo response in light of 
the high placebo response observed in one phase II trial. A population 
pharmacokinetic model describing the effect of formulations was included in the 
E-R simulation framework to assess potential dose implications of a formulation 
switch from phase II to phase III. Model-based simulations predict that a dose 
of 25 mg or higher is likely to achieve significantly better efficacy than 
placebo with desirable efficacy levels. The understanding of E-R helped support 
the dose selection for the phase III clinical trials.