A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection

September 8, 2015 updated by: Novartis Pharmaceuticals

An Open Label, Single Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum Malaria Mono-infection

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study.

cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Ratchabari, Thailand, 70180
        • Novartis Investigative Site
      • Srisaket, Thailand, 33140
        • Novartis Investigative Site
      • Tak, Thailand, 63140
        • Novartis Investigative Site
  • Vietnam
      • Hanoi, Vietnam, 10000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients aged 20 to 60 years
  • Presence of mono-infection of P. falciparum
  • Weight between 40 kg to 90 kg

Exclusion Criteria:

  • Patients with signs and symptoms of severe/complicated malaria
  • Mixed Plasmodium infection
  • Presence of other serious or chronic clinical condition requiring hospitalization.
  • Severe malnutrition
  • Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
Drug: KAE609
KAE609 75mg single dose
Drug: KAE609
KAE609 150mg single dose
Drug: KAE609
KAE609 225mg single dose
Drug: KAE609
KAE609 300mg single dose
Experimental: Cohort 2
6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose
Drug: KAE609
KAE609 75mg single dose
Drug: KAE609
KAE609 150mg single dose
Drug: KAE609
KAE609 225mg single dose
Drug: KAE609
KAE609 300mg single dose
Experimental: Cohort 3
6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose
Drug: KAE609
KAE609 75mg single dose
Drug: KAE609
KAE609 150mg single dose
Drug: KAE609
KAE609 225mg single dose
Drug: KAE609
KAE609 300mg single dose
Experimental: Cohort4
6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose
Drug: KAE609
KAE609 75mg single dose
Drug: KAE609
KAE609 150mg single dose
Drug: KAE609
KAE609 225mg single dose
Drug: KAE609
KAE609 300mg single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day Cure Rate
Time Frame: Day 28
28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 23, 2013

Study Record Updates

Last Update Posted (Estimate)

September 10, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKAE609X2202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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