Clinical trial NCT01753323: Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Keywords: acute malaria, KAF156
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility 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

Primary outcomes:
measure: Time to Parasite Clearance
timeFrame: Day 5
measure: 28-day Cure Rate - Part 2
timeFrame: Day 28
Secondary outcomes:
measure: Area Under the Curve (AUC)0-24h - Part 1
timeFrame: Days 1 and 3
measure: Maximum Concentration (Cmax) - Part 1
timeFrame: Days 1 and 3
measure: Time to Maximum Concentration (Tmax) - Part 1
timeFrame: Days 1 and 3
measure: Area Under the Curve (AUC)Last - Part 1
timeFrame: Day 3
measure: Area Under the Curve (AUC)Inf - Part 1
timeFrame: Day 3
measure: Half-life (T1/2) - Part 1
timeFrame: Day 3
measure: Clearance (CL/F ) - Part 1
timeFrame: Day 3
measure: Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) - Part 1
timeFrame: Day 3
measure: Accumulation Ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1) - Part 1
timeFrame: Day 3
measure: AUC0-24h - Part 2
timeFrame: Day 1
measure: AUC0-48h - Part 2
timeFrame: Day 1
measure: AUClast - Part 2
timeFrame: Day 1
measure: AUCinf - Part 2
timeFrame: Day 1
measure: Cmax - Part 2
timeFrame: Day 1
measure: Tmax - Part 2
timeFrame: Day 1
measure: T1/2 - Part 2
timeFrame: Day 1
measure: CL/F - Part 2
timeFrame: Day 1
measure: Vz/F - Part 2
timeFrame: Day 1
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Srisaket
country: Thailand
facility: Novartis Investigative Site
city: Tak
country: Thailand
facility: Novartis Investigative Site
city: Tak
country: Thailand
facility: Novartis Investigative Site
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.