A Study to Compare Zavegepant Concentration Using Samples Collected From the Vein Versus Patient-Centric Microsampling
Status:
Completed
Trial end date:
2023-09-05
Target enrollment:
Participant gender:
Summary
The purpose of this clinical trial is to learn about the pharmacokinetics and safety of a
drug called zavegepant from samples collected using a patient-centric device called
Tasso-Plus (for liquid blood sample collection) and Tasso-M20 (for dried blood sample
collection) compared to standard venous sample collection. This study consists of two periods
and will enroll approximately 14 healthy participants. In period 1, half of the enrolled
participants (n=7) will use Tasso-Plus, and the other 50% (n=7) will use Tasso-M20. For each
participant, PK samples will be collected after zavegepant administration in period 1 using
the assigned Tasso device simultaneously with collecting venous blood samples. In addition,
taste assessments will be performed at time intervals of 1 (immediately after dosing), 5, 10
and 20 minutes after zavegepant IN administration. Also, if feasible, 4 Japanese participants
will be enrolled among those 14 participants to evaluate the PK and safety of zavegepant IN
in Japanese vs. non Japanese participants. In period 2, a butterscotch candy will be given 5
minutes before administering the zavegepant IN study intervention. Taste assessment will also
be performed after zavegepant IN administration with a butterscotch candy in period 2. For
taste assessment, each participant will record the sensory attributes at timed intervals of 1
(immediately after dosing), 5, 10 and 20 minutes after zavegepant administration in each
period. The expected duration of participation from screening until follow-up telephone
contact is approximately 9 weeks.