NCT02631473

PK of Efavirenz & Lopinavir Nano-formulations in Healthy Volunteers

Pharmacokinetics of Efavirenz and Lopinavir Nano-formulations in HIV Negative Healthy Volunteers: an Adaptive Design Study

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: St Stephens Aids Trust · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label, prospective pharmacokinetic study investigating two antiretroviral agents in parallel and employing an adaptive design with two stages, whereby the results obtained in the primary stage inform the doses selected for investigation in the secondary stage

Detailed description

The objectives of this study are: Primary * To investigate the pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANO-efavirenz) in HIV negative healthy volunteers after single dose and a steady-state. * To investigate the pharmacokinetics of a new pharmaceutical formulation of lopinavir (NANO-lopinavir) in HIV negative healthy volunteers Secondary * To investigate the safety and tolerability of NANO-efavirenz and NANO-lopinavir in HIV negative healthy volunteers * To assess the bioequivalence of a selected single-dose of NANO-efavirenz to a single dose 600mg of efavirenz as Sustiva® * To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	50mg NANO-efavirenz	OD
DRUG	400mg NANO-Lopinavir	BID
DRUG	200mg NANO-Lopinavir	BID
DRUG	100mg Ritonavir	BID
DRUG	300mg NANO-Efavirenz	OD
DRUG	600mg Sustiva	OD
DRUG	200mg NANO-Efavirenz	OD
DRUG	Kaletra® (lopinavir 400mg/ritonavir 100mg)	BID
DRUG	+/- 200mg NANO-Lopinavir	BID
DRUG	+/- 200mg ritonavir NORVIR	BID
DRUG	400mg Sustiva

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-11-01
• First posted: 2015-12-16
• Last updated: 2016-12-07

Locations

1 site across 1 country: United Kingdom