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Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753323
First Posted: December 20, 2012
Last Update Posted: October 23, 2015
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400 mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)

Condition Intervention Phase
Malaria Drug: KAF156 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Proof-of-concept, Open Label Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Time to Parasite Clearance [ Time Frame: Day 5 ]
    Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and blood density assessments.

  • 28-day Cure Rate - Part 2 [ Time Frame: Day 28 ]
    28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment.


Secondary Outcome Measures:
  • Area Under the Curve (AUC)0-24h - Part 1 [ Time Frame: Days 1 and 3 ]
    AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose was taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • Maximum Concentration (Cmax) - Part 1 [ Time Frame: Days 1 and 3 ]
    Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • Time to Maximum Concentration (Tmax) - Part 1 [ Time Frame: Days 1 and 3 ]
    Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • Area Under the Curve (AUC)Last - Part 1 [ Time Frame: Day 3 ]
    AUClast was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • Area Under the Curve (AUC)Inf - Part 1 [ Time Frame: Day 3 ]
    AUCinf was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • Half-life (T1/2) - Part 1 [ Time Frame: Day 3 ]
    T1/2 was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • Clearance (CL/F ) - Part 1 [ Time Frame: Day 3 ]
    CL/F was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) - Part 1 [ Time Frame: Day 3 ]
    Vz/F was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • Accumulation Ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1) - Part 1 [ Time Frame: Day 3 ]
    Racc was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • AUC0-24h - Part 2 [ Time Frame: Day 1 ]
    AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.

  • AUC0-48h - Part 2 [ Time Frame: Day 1 ]
    AUC0-48h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • AUClast - Part 2 [ Time Frame: Day 1 ]
    AUClast was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose

  • AUCinf - Part 2 [ Time Frame: Day 1 ]
    AUCinf was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose

  • Cmax - Part 2 [ Time Frame: Day 1 ]
    Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.

  • Tmax - Part 2 [ Time Frame: Day 1 ]
    Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.

  • T1/2 - Part 2 [ Time Frame: Day 1 ]
    T1/2 was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • CL/F - Part 2 [ Time Frame: Day 1 ]
    CL/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.

  • Vz/F - Part 2 [ Time Frame: Day 1 ]
    Vz/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.


Enrollment: 43
Study Start Date: March 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 - Cohort 1: P. vivax: KAF156 400mg QD
Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
Drug: KAF156
KAF156 was supplied as tablets for oral use.
Experimental: Part 1 - Cohort 2: P. falciparum: KAF156 400mg QD
Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
Drug: KAF156
KAF156 was supplied as tablets for oral use.
Experimental: Part 2 - Cohort 3: P. falciparum: KAF156 800mg single dose
Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
Drug: KAF156
KAF156 was supplied as tablets for oral use.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 or P. vivax; Weight between 40 kg to 90 kg.

Exclusion Criteria:

  • Patients with signs and symptoms of severe/complicated malaria
  • Infection with more than one parasite species
  • Women of child-bearing potential; pregnant or nursing women
  • Those who have taken any anti-malarial treatment in the preceding 14 days or other investigational drugs within 30 days or 5 half-lives
  Contacts and Locations
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): NCT01753323


Locations
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10400
Novartis Investigative Site
Srisaket, Thailand, 33140
Novartis Investigative Site
Tak, Thailand, 63110
Novartis Investigative Site
Tak, Thailand, 63140
Vietnam
Novartis Investigative Site
Hanoi, Vietnam, 10000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01753323     History of Changes
Other Study ID Numbers: CKAF156X2201
First Submitted: December 17, 2012
First Posted: December 20, 2012
Results First Submitted: July 23, 2015
Results First Posted: August 19, 2015
Last Update Posted: October 23, 2015
Last Verified: October 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
acute malaria, KAF156

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases