NCT02888327

A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872

A Phase-1, Open-label, Four Group, Fixed-Sequence Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir, JNJ-63623872, and Probes for P-glycoprotein, CYP3A and OATP1B1 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Alios Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This open-label, four group, fixed-sequence study will evaluate the safety and pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers.

Detailed description

This open-label, four group, fixed-sequence study will evaluate the safety and pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers. For each group, the study consists of an eligibility screening period, study period, and 1 follow-up visit. Groups may enroll in parallel but subjects enrolled in one group may not participate in another group.

Conditions

• Influenza in Humans

Interventions

Type	Name	Description
DRUG	AL-794
DRUG	Oseltamivir
DRUG	Digoxin
DRUG	Midazolam
DRUG	Pitavastatin
DRUG	JNJ-63623872

Timeline

• Start date: 2016-07-31
• Primary completion: 2017-05-30
• Completion: 2017-05-30
• First posted: 2016-09-05
• Last updated: 2025-02-03

Locations

1 site across 1 country: United Kingdom