Trial · NCT01753323
Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
NCT01753323, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection. Trials, record NCT01753323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01753323
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
- NCT number
- NCT01753323
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Malaria
- Interventions
- KAF156
- First posted
- 2012-12-20
- Last updated
- 2018-06-07
- Results first posted
- 2015-08-19
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Parasite Clearance | Day 5 | Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and blood density assessments. |
| Primary | 28-day Cure Rate - Part 2 | Day 28 | 28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment. |
| Secondary | Area Under the Curve (AUC)0-24h - Part 1 | Days 1 and 3 | 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. |
| Secondary | Maximum Concentration (Cmax) - Part 1 | Days 1 and 3 | 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. |
| Secondary | Time to Maximum Concentration (Tmax) - Part 1 | Days 1 and 3 | 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. |
| Secondary | Area Under the Curve (AUC)Last - Part 1 | Day 3 | 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. |
| Secondary | Area Under the Curve (AUC)Inf - Part 1 | Day 3 | 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. |
| Secondary | Half-life (T1/2) - Part 1 | Day 3 | 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. |
| Secondary | Clearance (CL/F ) - Part 1 | Day 3 | 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. |
| Secondary | Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) - Part 1 | Day 3 | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Parasite Clearance | Day 5 | 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. | Hours | MEDIAN |
| PRIMARY | 28-day Cure Rate - Part 2 | Day 28 | Intent-to-treat analysis set: the intent-to-treat analysis set included all randomized participants who received at least one dose of study medication. | Percentage of participants | NUMBER |
| SECONDARY | Area Under the Curve (AUC)0-24h - Part 1 | Days 1 and 3 | 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. | (hr*ng/mL) | MEAN |
| SECONDARY | Maximum Concentration (Cmax) - Part 1 | Days 1 and 3 | 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. | ng/mL | MEAN |
| SECONDARY | Time to Maximum Concentration (Tmax) - Part 1 | Days 1 and 3 | 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. | hour | MEDIAN |
| SECONDARY | Area Under the Curve (AUC)Last - Part 1 | Day 3 | 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. | hr*ng/mL | MEAN |
| SECONDARY | Area Under the Curve (AUC)Inf - Part 1 | Day 3 | 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. | hr*ng/mL | MEAN |
| SECONDARY | Half-life (T1/2) - Part 1 | Day 3 | 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. | hr | MEAN |
| SECONDARY | Clearance (CL/F ) - Part 1 | Day 3 | 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. | L/hr | MEAN |
| SECONDARY | Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) - Part 1 | Day 3 | 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. | Liters | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Parasite Clearance | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 23.63 | 95% Confidence Interval 16.00 to 30.02 | Hours | |
| Time to Parasite Clearance | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | 44.97 | 95% Confidence Interval 36.25 to 47.98 | Hours | |
| Time to Parasite Clearance | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | 48.75 | 95% Confidence Interval 42.00 to 53.95 | Hours | |
| 28-day Cure Rate - Part 2 | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | 63.6 | Percentage of participants | ||
| Area Under the Curve (AUC)0-24h - Part 1 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Day 1 | 9470 | Standard Deviation 2140 | (hr*ng/mL) |
| Area Under the Curve (AUC)0-24h - Part 1 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Day 1 | 10100 | Standard Deviation 2440 | (hr*ng/mL) |
| Area Under the Curve (AUC)0-24h - Part 1 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Day 3 | 20200 | Standard Deviation 3730 | (hr*ng/mL) |
| Area Under the Curve (AUC)0-24h - Part 1 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Day 3 | 21700 | Standard Deviation 6630 | (hr*ng/mL) |
| Maximum Concentration (Cmax) - Part 1 | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | Day 1 | 795 | Standard Error 182 | ng/mL |
| Maximum Concentration (Cmax) - Part 1 | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | Day 1 | 856 | Standard Error 158 | ng/mL |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 11 | |
| Overall Study | STARTED | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | 10 | |
| Overall Study | STARTED | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | 22 | |
| Overall Study | Pharmacodynamic (PD) Set | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 10 | |
| Overall Study | Pharmacodynamic (PD) Set | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | 10 | |
| Overall Study | Pharmacodynamic (PD) Set | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | 21 | |
| Overall Study | Pharmacokinetic(PK) Set | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 10 | |
| Overall Study | Pharmacokinetic(PK) Set | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | 10 | |
| Overall Study | Pharmacokinetic(PK) Set | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | 21 | |
| Overall Study | Safety Set | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 11 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | 1 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | 7 | 22 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 0 | 11 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | 0 | 10 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | 1 | 22 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 0 | 11 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | 0 | 10 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | 4 | 22 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 0 | 11 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | ||
| Total, all-cause mortality | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | ||
| Total, all-cause mortality | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | ||
| Total, other adverse events | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 5 | 11 |
| Total, other adverse events | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | 8 | 10 |
| Total, other adverse events | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | 22 | 22 |
| Total, serious adverse events | Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD | 0 | 11 |
| Total, serious adverse events | Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD | 0 | 10 |
| Total, serious adverse events | Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose | 0 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27653565 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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