Phase 2
N=43
Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT01753323 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Time to Parasite Clearance — 23.63; 44.97; 48.75 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KAF156 (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Parasite Clearance |
23.63; 44.97; 48.75 | — |
| PRIMARY 28-day Cure Rate - Part 2 |
63.6 | — |
| SECONDARY Area Under the Curve (AUC)0-24h - Part 1 |
9470; 10100; 20200; 21700 | — |
| SECONDARY Maximum Concentration (Cmax) - Part 1 |
795; 856; 1440; 1620 | — |
| SECONDARY Time to Maximum Concentration (Tmax) - Part 1 |
3.00; 3.00; 3.00; 2.52 | — |
| SECONDARY Area Under the Curve (AUC)Last - Part 1 |
55800; 54300 | — |
| SECONDARY Area Under the Curve (AUC)Inf - Part 1 |
58300; 56700 | — |
| SECONDARY Half-life (T1/2) - Part 1 |
39.0; 40.8 | — |
| SECONDARY Clearance (CL/F ) - Part 1 |
20.4; 19.7 | — |
| SECONDARY Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) - Part 1 |
1150; 1140 | — |
| SECONDARY Accumulation Ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1) - Part 1 |
2.16; 2.15 | — |
| SECONDARY AUC0-24h - Part 2 |
21700 | — |
| SECONDARY AUC0-48h - Part 2 |
33600 | — |
| SECONDARY AUClast - Part 2 |
54900 | — |
| SECONDARY AUCinf - Part 2 |
58300 | — |
| SECONDARY Cmax - Part 2 |
1800 | — |
| SECONDARY Tmax - Part 2 |
3.52 | — |
| SECONDARY T1/2 - Part 2 |
48.7 | — |
| SECONDARY CL/F - Part 2 |
15.1 | — |
| SECONDARY Vz/F - Part 2 |
1030 | — |
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
Data sourced from ClinicalTrials.gov (NCT01753323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.