A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.
This Phase 1 study in healthy subjects is being conducted to assess the safety, tolerability, and pharmacokinetics of N91115. Also, a comparison of the fasted versus fed with a high fat meal were compared for PK.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
DaVita Clinical Research
Lakewood, Colorado, United States
Safety and Tolerability of N91115
Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Time frame: 21 Days
Pharmacokinetics: Day 1 AUClast
Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration
Time frame: Day 1
Pharmacokinetics: AUCtau Day 14
Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115
Time frame: Day 14
Pharmacokinetics: Day 1 Plasma Cmax Values
All subjects who completed sample collections for Day 1 plasma N91115
Time frame: Day 1
Pharmacokinetics: Plasma Cmax Values on Day 14
Plasma Cmax values from Day 14 subjects with repeat administration of N91115
Time frame: Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Given PO- only on Day 1 (single dosed to match single dose treatments)