The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects.
This study will assess the effects of multiple oral dose administration of rifampin on the steady state plasma pharmacokinetics (PK) of N91115 in healthy subjects. Eligible subjects (n=15) will receive oral doses of N91115 twice daily (approximately every 12 hours) on Study Days 1 through the morning of Day 13. On Study Days 8 through 12, rifampin administered 600 mg once daily will be added to the N91115 regimen. Study subjects will be monitored for safety while housed in the clinical research unit (CRU) until discharge on Day 14. Pharmacokinetics will be followed from Study Day 1 through Study Day 14. A follow-up phone call will be made on Day 20 (1 day). Participation of an individual subject may last up to approximately 48 days from the time of screening until the end-of-study follow-up call.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
15
St. Anthony's Medical Plaza 1
Lakewood, Colorado, United States
Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values
To assess the effects of multiple oral dose administration of rifampin on the steady state AUC on Day 14 of N91115 in healthy subjects.
Time frame: On Study Day 14
Effects of Rifampin on the AUC vs time of Metabolites of N91115
make a preliminary non statistical assessment on the effects of multiple oral dose administration of rifampin on steady state plasma PK of N91288 and metabolites, in healthy subjects
Time frame: On Study Day 14
The number of participants with adverse events
To evaluate the safety and tolerability of multiple oral doses of N91115 in the presence and absence of multiple oral doses of rifampin
Time frame: Over the 21 days of the study
Effects of Rifampin on N91115 and its Metabolites on Urine 12 Hour drug concentrations
To make a preliminary non statistical assessment on the effects of multiple oral dose administration of rifampin on the 12 hour steady state urine PK of N91115 and its primary metabolites in healthy subjects
Time frame: Day 14 assessment
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