Drug Interaction Potentiation Clinical Trial
Official title:
A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Steady State Pharmacokinetics of N91115 Alone and in the Presence of Multiple Dose Administration of Rifampin in Healthy Adult Subjects (SNO-5)
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.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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