| Primary | Time to Parasite Clearance | Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and blood density assessments. | Pharmacodynamic (PD) analysis set for Cohorts 1, 2 and 3: The PD set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation, and 1 participant from Cohort 3, who was withdrawn on Day 1. | Posted | | Median | 95% Confidence Interval | Hours | | Day 5 | | | | ID | Title | Description |
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| OG000 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. | | OG001 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. | | OG002 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00023.63(16.00 to 30.02)
- OG00144.97(36.25 to 47.98)
- OG00248.75(42.00 to 53.95)
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| Primary | 28-day Cure Rate - Part 2 | 28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment. | Intent-to-treat analysis set: the intent-to-treat analysis set included all randomized participants who received at least one dose of study medication. | Posted | | Number | | Percentage of participants | | Day 28 | | | | ID | Title | Description |
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| OG000 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
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| Secondary | Area Under the Curve (AUC)0-24h - Part 1 | AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose was taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation. | Posted | | Mean | Standard Deviation | (hr*ng/mL) | | Days 1 and 3 | | | | ID | Title | Description |
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| OG000 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. | | OG001 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. |
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| Secondary | Maximum Concentration (Cmax) - Part 1 | Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation. | Posted | | Mean | Standard Error | ng/mL | | Days 1 and 3 | | | | ID | Title | Description |
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| OG000 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. | | OG001 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. |
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| Secondary | Time to Maximum Concentration (Tmax) - Part 1 | Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation. | Posted | | Median | Full Range | hour | | Days 1 and 3 | | | | ID | Title | Description |
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| OG000 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. | | OG001 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. |
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| Secondary | Area Under the Curve (AUC)Last - Part 1 | AUClast was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation. | Posted | | Mean | Standard Error | hr*ng/mL | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. | | OG001 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. |
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| Secondary | Area Under the Curve (AUC)Inf - Part 1 | AUCinf was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation. | Posted | | Mean | Standard Deviation | hr*ng/mL | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. | | OG001 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. |
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| Secondary | Half-life (T1/2) - Part 1 | T1/2 was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation. | Posted | | Mean | Standard Deviation | hr | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. | | OG001 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. |
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| Secondary | Clearance (CL/F ) - Part 1 | CL/F was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation. | Posted | | Mean | Standard Deviation | L/hr | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. | | OG001 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. |
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| Secondary | Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) - Part 1 | Vz/F was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation. | Posted | | Mean | Standard Deviation | Liters | | Day 3 | | | | ID | Title | Description |
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| OG000 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. | | OG001 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. |
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| Secondary | Accumulation Ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1) - Part 1 | Racc was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation. | Posted | | Mean | Standard Deviation | ratio | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. | | OG001 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. |
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| Secondary | AUC0-24h - Part 2 | AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. | Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours. | Posted | | Mean | Standard Error | hr*ng/mL | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
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| Secondary | AUC0-48h - Part 2 | AUC0-48h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours. | Posted | | Mean | Standard Error | hr*ng/mL | | Day 1 | | | | ID | Title | Description |
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| OG000 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
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| Secondary | AUClast - Part 2 | AUClast was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose | Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours. | Posted | | Mean | Standard Deviation | hr*ng/mL | | Day 1 | | | | ID | Title | Description |
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| OG000 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
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| Secondary | AUCinf - Part 2 | AUCinf was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose | Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours. | Posted | | Mean | Standard Deviation | hr*ng/mL | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
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| Secondary | Cmax - Part 2 | Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. | Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 | | | | ID | Title | Description |
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| OG000 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
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| Secondary | Tmax - Part 2 | Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. | Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours. | Posted | | Median | Full Range | hours | | Day 1 | | | | ID | Title | Description |
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| OG000 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
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| Secondary | T1/2 - Part 2 | T1/2 was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours. | Posted | | Mean | Standard Deviation | hours | | Day 1 | | | | ID | Title | Description |
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| OG000 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
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| Secondary | CL/F - Part 2 | CL/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who who vomited before 3 hours. | Posted | | Mean | Standard Deviation | L/hr | | Day 1 | | | | ID | Title | Description |
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| OG000 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
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| Secondary | Vz/F - Part 2 | Vz/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose. | Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours. | Posted | | Mean | Standard Deviation | Liters | | Day 1 | | | | ID | Title | Description |
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| OG000 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg. |
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