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Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects

NCT01660022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2015-01-21

Study results available
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Summary

A Phase I Study to investigate the safety, tolerability \& pharmacokinetics of co-administered single doses of OZ439 and Piperaquine to healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

100mg OZ439 single oral dose

100mg OZ439 oral suspension single dose

DRUG

Placebo

Placebo

DRUG

300 mg OZ439 single oral dose

300mg OZ439 oral suspension single dose

DRUG

160mg Piperaquine single oral dose

160 mg Piperaquine tablet

DRUG

480mg Piperaquine single oral dose

480 mg Piperaquine tablet

DRUG

1440mg Piperaquine single oral dose

1440 mg Piperaquine tablet

DRUG

800 mg OZ439 single oral dose

800mg OZ439 oral suspension single dose

Sponsors & Collaborators

  • Cross Research S.A.

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Milko M Radicioni, MD PhD · Cross Research S.A.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT01660022 on ClinicalTrials.gov