Cure Rate
Conditions
Keywords
parasitemia
Brief summary
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day
Detailed description
the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study. cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.
Interventions
DRUGKAE609
KAE609 75mg single dose
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients aged 20 to 60 years * Presence of mono-infection of P. falciparum * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day Cure Rate | Day 28 | 28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film). |
Countries
Thailand, Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total - Cohort 1 Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unsatisfactory therapeutic | 5 |
Baseline characteristics
| Characteristic | Total - Cohort 1 |
|---|---|
| Age, Continuous | 31.6 years STANDARD_DEVIATION 7.5 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 11 |
| serious Total, serious adverse events | 3 / 11 |
Outcome results
Primary
28-day Cure Rate
28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).
Time frame: Day 28
Population: PharmacoDynamic (PD) Analysis Set - All the 11 patients were included in PD analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total - Cohort 1 | 28-day Cure Rate | 63.67 Percentage of participants |