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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01860989
Recruitment Status : Completed
First Posted : May 23, 2013
Results First Posted : September 3, 2015
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Cure Rate Drug: KAE609 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
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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
Experimental: Cohort 2
6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose
 Drug: KAE609
KAE609 150mg 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 225mg single dose
Experimental: Cohort4
6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose
 Drug: KAE609
KAE609 300mg single dose


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860989


Locations
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Thailand
Novartis Investigative Site
Ratchabari, Thailand, 70180
Novartis Investigative Site
Srisaket, Thailand, 33140
Novartis Investigative Site
Tak, Thailand, 63140
Vietnam
Novartis Investigative Site
Hanoi, Vietnam, 10000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01860989    
Other Study ID Numbers: CKAE609X2202
First Posted: May 23, 2013    Key Record Dates
Results First Posted: September 3, 2015
Last Update Posted: September 10, 2015
Last Verified: September 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
parasitemia
Additional relevant MeSH terms:
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Malaria
Infections
Protozoan Infections
Parasitic Diseases
Vector Borne Diseases