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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Apparent terminal elimination rate constant (Kel)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MIV-711 ABCD
Subjects will first receive the tablet formulation under fasted conditions (A) followed by the tablet formulation administered under fed conditions (B). Thereafter they will receive the capsule formulation under fasted conditions (C) followed by the capsule formulation administered under fed conditions (D).
Intervention: MIV-711 (Drug)
MIV-711 CDAB
Subjects will first receive the capsule formulation under fasted conditions (C)followed by the capsule formulation administered under fed conditions (D). Thereafter they will receive the tablet formulation under fasted conditions (A) followed by the tablet formulation administered under fed conditions (B).
Intervention: MIV-711 (Drug)
Outcomes
Primary Outcomes
Apparent terminal elimination rate constant (Kel)
Time Frame: 0 to 72 hours post dose
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.
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t)
Time Frame: 0 to 72 hours post dose
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.
Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf)
Time Frame: 0 to 72 hours post dose
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.
Maximum observed concentration (Cmax)
Time Frame: 0 to 72 hours post dose
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 to reach maximum observed concentration (Tmax)
Time Frame: 0 to 72 hours post dose
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.
Apparent terminal elimination half-life (T½)
Time Frame: 0 to 72 hours post dose
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.
Secondary Outcomes
- The number and severity of AEs/SAE(from study start until 7+/-2 days after the last study drug administration)
- The number of clinically significant abnormal lab results(from study start until 7+/-2 days after the last study drug administration)
- The number of clinically significant ECG abnormalities(from study start until 7+/-2 days after the last study drug administration)
- The number of clinically significant physical examination abnormalities(from study start until 7+/-2 days after the last study drug administration)