This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
18
MIV-711 administered as tablets and capsules at four occasions
Celerion
Lincoln, Nebraska, United States
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Time frame: 0 to 72 hours post dose
Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Time frame: 0 to 72 hours post dose
Maximum observed concentration (Cmax)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Time frame: 0 to 72 hours post dose
Time to reach maximum observed concentration (Tmax)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Time frame: 0 to 72 hours post dose
Apparent terminal elimination rate constant (Kel)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Time frame: 0 to 72 hours post dose
Apparent terminal elimination half-life (T½)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
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Time frame: 0 to 72 hours post dose
The number and severity of AEs/SAE
Safety and tolerability of MIV-711 measured by number and severity of AEs/SAEs
Time frame: from study start until 7+/-2 days after the last study drug administration
The number of clinically significant abnormal lab results
Safety and tolerability of MIV-711 measured by number of clinical significant abnormal lab results.
Time frame: from study start until 7+/-2 days after the last study drug administration
The number of clinically significant ECG abnormalities
Safety and tolerability of MIV-711 measured by number of clinical significant ECG abnormalities.
Time frame: from study start until 7+/-2 days after the last study drug administration
The number of clinically significant physical examination abnormalities
Safety and tolerability of MIV-711 measured by number of clinical significant physical examination abnormalities.
Time frame: from study start until 7+/-2 days after the last study drug administration