NCT02500667

A Drug-Drug Interaction Study of N91115 +/- Rifampin in Healthy Adult Subjects

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Nivalis Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects.

Detailed description

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.

Conditions

• Drug Interaction Potentiation

Interventions

Type	Name	Description
DRUG	N91115	200 mg BID
DRUG	Rifampin	600 mg QD

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-07-16
• Last updated: 2016-11-07

Locations

1 site across 1 country: United States