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Absolute BA and OZ439 PK Effect of Different OZ439 Dose Volumes and Cobicistat Co-administration Study

NCT04069221 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-11-26

Study results available
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Summary

This study is an open-label, two-part study to determine the absolute bioavailability (BA) of OZ439 using simultaneous intravenous \[14C\]-OZ439 microdose/800mg oral dosing and to investigate the pharmacokinetics (PK) of OZ439 granules administered as single doses suspended in different volumes and when co-administered with a single dose of Cobicistat, a strong CYP3A4 inhibitor, to healthy subjects in fasted state.

Conditions

Interventions

DRUG

Single oral dose of 800 mg OZ439

Single oral dose of 800 mg OZ439

DRUG

Single oral dose of 400 mg OZ439

Single oral dose of 400 mg OZ439

DRUG

Single oral dose of cobicistat

Single oral dose of 150 mg cobicistat

DRUG

iv infusion of [14C]-OZ439

15-minute 10-mL iv infusion of 100 μg \[14C\]-OZ439

Sponsors & Collaborators

  • Medicines for Malaria Venture

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2017-05-30
Completion
2017-05-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069221 on ClinicalTrials.gov