A Proof-of-concept, Open Label, 3-day Repeated Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Parasite clearance time
Study Overview
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 KAE609 at 30 mg/day
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Mixed Plasmodium infection
- •Presence of other serious or chronic clinical condition requiring hospitalization.
- •Severe malnutrition
- •Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study
- •Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
Cohort 1
10 subjects with Plasmodium vivax malaria will receive 30 mg KAE609 once a day for three days
Intervention: KAE609 (Drug)
Cohort 2
10 subjects with Plasmodium falciparum malaria will receive 30 mg KAE609 once a day for three days
Intervention: KAE609 (Drug)
Outcomes
Primary Outcomes
Parasite clearance time
Time Frame: From baseline to the time point when the blood parasite count is zero(up to a maximum of 5 days)
Calculated based on parasite count in blood. In thin film, use actual WBCs/µl, of blood to calculate parasite density by using the following formula: parasites/µl= #parasites× actual WBC/#WBCs counted. In thick film, assume that there are 250 RBCs per HPF, RBC count from 8 HPF equal 2000 RBC, Use actual RBCs/µl blood to calculate parasite density by using the following formula: parasites/µl= # of parasites in 8HPF/2000)× actual RBC.
Secondary Outcomes
- Number of participants with adverse events(vital signs: Days 1 through 6; ECG: Days1, 2, 3; Labs: Days 2, 3, 5, study completion)
- Area under the curve (AUC)0-24h on Day 1 and Day 3(Day 1 and Day 3)
- The accumulation ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1)(Day 1 and Day 3)
- Maximum concentration (Cmax) on Day 1 and Day 3(Day 1 and Day 3)
- Time to maximum concentration (Tmax) on Day 1 and Day 3(Day 1 and Day 3)
- Half-life (T1/2)(Day 3)
- Clearance (CL/F )(Day 3)
- The apparent volume of distribution during the terminal elimination phase following extravascular administration (Vz/F)(Day 3)