Healthy Volunteers Clinical Trial
Official title:
Relative Bioavailability Study of an Extended Release (ER) Tablet Formulation of MN-166 (Ibudilast) Compared to an Intermediate Release (IR) Capsule Formulation in Healthy Volunteers
This study will investigate the PK, relative bioavailability, safety, and tolerability of the extended release (ER) 50 mg MN-166 (ibudilast) tablet formulation as compared to the intermediate-release (IR) capsule formulation of MN-166 (ibudilast) and to examine the effect of food on the pharmacokinetics of the ER formulation.
This is a Phase 1, open-label, single-center study in at least 12 healthy volunteers or
participants.
Participants (at least n=2/sequence) meeting study eligibility and providing informed consent
will be randomized to one of six treatment sequences. The three treatments of each sequence
will be administered in a crossover fashion, separated by one week apart. Thus, participation
in the study is 3 weeks long per participant.
During each single-dose treatment, participants will check in the study facility the night
before dosing and remain at the facility until 32 hours after dosing. For example, the
participant would arrive at the study facility at 8:00 PM Sunday night, receive a single dose
at 8:00 AM Monday morning, and blood samples will be taken prior to dosing and 30 minutes, 1,
2 4, 6, 8, 10, 12, 24, and 32 hours after dosing. After the 32-hour sample collection,
participants may leave the study facility. Participants will return to the study facility for
outpatient visits at each remaining PK sampling day (48, 72, and 96 hours after dosing) and
after last treatment in each sequence. Participants will be discharged from the study after
the last treatment.
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