NCT01753323

Brief Summary

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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 19, 2015

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

December 17, 2012

Results QC Date

July 23, 2015

Last Update Submit

June 4, 2018

Conditions

Malaria

Keywords

acute malaria, KAF156

Outcome Measures

Primary Outcomes (2)

  • Time to Parasite Clearance

    Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and blood density assessments.

    Day 5

  • 28-day Cure Rate - Part 2

    28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment.

    Day 28

Secondary Outcomes (18)

  • Area Under the Curve (AUC)0-24h - Part 1

    Days 1 and 3

  • Maximum Concentration (Cmax) - Part 1

    Days 1 and 3

  • Time to Maximum Concentration (Tmax) - Part 1

    Days 1 and 3

  • Area Under the Curve (AUC)Last - Part 1

    Day 3

  • Area Under the Curve (AUC)Inf - Part 1

    Day 3

  • +13 more secondary outcomes

Study Arms (3)

Part 1 - Cohort 1: P. vivax: KAF156 400mg QD

EXPERIMENTAL

Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.

Drug: KAF156

Part 1 - Cohort 2: P. falciparum: KAF156 400mg QD

EXPERIMENTAL

Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.

Drug: KAF156

Part 2 - Cohort 3: P. falciparum: KAF156 800mg single dose

EXPERIMENTAL

Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.

Drug: KAF156

Interventions

KAF156DRUG

KAF156 was supplied as tablets for oral use.

Part 1 - Cohort 1: P. vivax: KAF156 400mg QDPart 1 - Cohort 2: P. falciparum: KAF156 400mg QDPart 2 - Cohort 3: P. falciparum: KAF156 800mg single dose

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Si Sa Ket, 33140, Thailand

Location

Novartis Investigative Site

Tak, 63110, Thailand

Location

Novartis Investigative Site

Tak, 63140, Thailand

Location

Novartis Investigative Site

Hanoi, 10000, Vietnam

Location

Related Publications (1)

  • White NJ, Duong TT, Uthaisin C, Nosten F, Phyo AP, Hanboonkunupakarn B, Pukrittayakamee S, Jittamala P, Chuthasmit K, Cheung MS, Feng Y, Li R, Magnusson B, Sultan M, Wieser D, Xun X, Zhao R, Diagana TT, Pertel P, Leong FJ. Antimalarial Activity of KAF156 in Falciparum and Vivax Malaria. N Engl J Med. 2016 Sep 22;375(12):1152-60. doi: 10.1056/NEJMoa1602250.

    PMID: 27653565DERIVED

MeSH Terms

Conditions

MalariaAcute malaria

Interventions

ganaplacide

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 20, 2012

Study Start

March 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 7, 2018

Results First Posted

August 19, 2015

Record last verified: 2018-06

Locations

TH(4)VN(1)