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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-08-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

KAF156

Intervention Type DRUG

KAF156 was supplied as tablets for oral use.

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

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

Group Type EXPERIMENTAL

KAF156

Intervention Type DRUG

KAF156 was supplied as tablets for oral use.

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

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

Group Type EXPERIMENTAL

KAF156

Intervention Type DRUG

KAF156 was supplied as tablets for oral use.

Interventions

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KAF156

KAF156 was supplied as tablets for oral use.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No