MalariaPhase 2NCT01836458
A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection
A Phase 2 study testing KAE609 in people with Malaria, run by Novartis Pharmaceuticals at 1 site in Vietnam.
Trial summary
This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609 Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Malaria
- What is being tested?
- KAE609
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteVietnam
- Study dates
- Jan 2014to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Monoinfection with P. falciparum confirmed by microscopy
- Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
- Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
- Body weight between 40 to 90 kg
Who cannot join
- Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
- Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
- Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
- History of antimalarial use within 2 months of screening
- Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
- Long QT syndrome or QTc using Fridericia's formula >430 msec
Show all 16Show fewer
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
- Hemoglobin level <10 g/dL
- Liver disease or injury as indicated by elevated liver tests such as SGPT (ALT) or SGOT (AST) >2 times the upper limit of normal
- Renal dysfunction as indicated by serum creatinine >2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be <2 times the upper limit of normal after oral or parental rehydration
- Known to be immunocompromised (including HIV infection) or are receiving immunosuppressive therapy at the time or enrollment; HIV testing is not required
- Known history of hepatitis B or C; testing is not required
- Febrile condition due to diseases other than malaria (e.g. acute lower respiratory tract infection), known underlying chronic or severe disease (e.g. cardiac, hepatic, renal, gastrointestinal, neurologic, or psychiatric disease), or any condition precluding enrollment into this study according to the investigator
- Severe vomiting defined as >3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours
- Severe malnutrition defined by a body mass index (BMI) <18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting
- Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study to Find the Minimum Inhibitory Concentration(MIC) of KAE609 in Adult Male Patients With Acute, Uncomplicated Malaria Due to Plasmodium Falciparum Monoinfection
This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609
Read the detailed description
There will be a total of approximately 45 patients recruited into this study and six doses of KAE609 and will be investigated.The dose groups will run in sequence. Patient will be given a single dose of KAE609 and be followed up for 42 days.
- Conditions
- Malaria
- Being tested
- KAE609
- Keywords
- Malaria, KAE609
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAE609Drug
Patients will receive KAE609 single dose at a different dose level in each cohort.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1: 30 mg | Experimental | Single dose of KAE609 30 mg Receives: Drug: KAE609 |
| Dose 2: 20 mg | Experimental | Single dose of KAE609 20 mg Receives: Drug: KAE609 |
| Dose 3: 10 mg | Experimental | Single dose of KAE609 10 mg Receives: Drug: KAE609 |
| Dose 4: 15 mg | Experimental | Single dose of KAE609 15 mg Receives: Drug: KAE609 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Inhibitory Concentration (MIC) of KAE609
To observe the exposure-response (PK/PD) relationship for a single dose of KAE609. The key parameter is MIC, defined as the concentration at which the relative rate of change in parasitemia is equal to zero. Approximation of MIC will assist in identifying the optimal dose of KAE609, which will be one component of a future combination antimalarial. MIC could not be determined due to small sample size no data was collected from any participants.
Measured: Up to Day 8 after a single dose of KAE609
Secondary outcomes (3)
Median Time to Parasite Clearance
Parasite clearance time will be estimated using thick/thin blood films.
Measured: pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, 54, 60, 66, 72 hours post dose of KAE609
Median Time to Fever Clearance
Fever is monitored on participants every 4 hours for the first 24 hours, then every 6 hours until negative reading obtained.
Measured: Day 1 to Day 5
Percentage of Patients PCR-corrected Cure Rate by Day 28, Day 35 & Day 42
PCR-corrected cure rate after a single dose of KAE609 by Day 28, Day 35 \& Day 42. PCR-corrected cure rate accounts for failures due to reappearance of parasites that were present in the blood before treatment (i.e. recrudescent infection) but not for failures due to a post-treatment inoculation (i.e. new infection).
Measured: Day 28, Day 35 & Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836458
- Sponsor's protocol ID
- CKAE609A2201
- Status last verified
- Sep 2016
- First submitted
- 17 Apr 2013
- Last updated
- 31 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hien TT, White NJ, Thuy-Nhien NT, Hoa NT, Thuan PD, Tarning J, Nosten F, Magnusson B, Jain JP, Hamed K. Estimation of the In Vivo MIC of Cipargamin in Uncomplicated Plasmodium falciparum Malaria. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01940-16. doi: 10.1128/AAC.01940-16. Print 2017 Feb.
PubMed 27872070
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Find the Minimum Inhibitory Concentration(MIC) of KAE609 in Adult Male Patients With Acute, Uncomplicated Malaria Due to Plasmodium Falciparum Monoinfection
- ClinicalTrials.gov ID
- NCT01836458
- Acronym / sponsor ID
- CKAE609A2201
- Conditions
- Malaria
- Keywords
- Malaria, KAE609
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609
Detailed description
There will be a total of approximately 45 patients recruited into this study and six doses of KAE609 and will be investigated.The dose groups will run in sequence. Patient will be given a single dose of KAE609 and be followed up for 42 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1: 30 mg | Experimental | Drug: KAE609Single dose of KAE609 30 mg |
| Dose 2: 20 mg | Experimental | Drug: KAE609Single dose of KAE609 20 mg |
| Dose 3: 10 mg | Experimental | Drug: KAE609Single dose of KAE609 10 mg |
| Dose 4: 15 mg | Experimental | Drug: KAE609Single dose of KAE609 15 mg |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Monoinfection with P. falciparum confirmed by microscopy
- Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
- Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
- Body weight between 40 to 90 kg
Key exclusion criteria (16 listed)
- Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
- Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
- Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
- History of antimalarial use within 2 months of screening
- Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAE609Patients will receive KAE609 single dose at a different dose level in each cohort. | Drug | Dose 1: 30 mg, Dose 2: 20 mg, Dose 3: 10 mg, Dose 4: 15 mg |
Primary outcome
Minimum Inhibitory Concentration (MIC) of KAE609
Time frame: Up to Day 8 after a single dose of KAE609
To observe the exposure-response (PK/PD) relationship for a single dose of KAE609. The key parameter is MIC, defined as the concentration at which the relative rate of change in parasitemia is equal to zero. Approximation of MIC will assist in identifying the optimal dose of KAE609, which will be one component of a future combination antimalarial. MIC could not be determined due to small sample size no data was collected from any participants.
3 secondary outcomes
Median Time to Parasite Clearance
Time frame: pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, 54, 60, 66, 72 hours post dose of KAE609
Median Time to Fever Clearance
Time frame: Day 1 to Day 5
Percentage of Patients PCR-corrected Cure Rate by Day 28, Day 35 & Day 42
Time frame: Day 28, Day 35 & Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27872070Hien TT, White NJ, Thuy-Nhien NT, Hoa NT, Thuan PD, Tarning J, Nosten F, Magnusson B, Jain JP, Hamed K. Estimation of the In Vivo MIC of Cipargamin in Uncomplicated Plasmodium falciparum Malaria. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01940-16. doi: 10.1128/AAC.01940-16. Print 2017 Feb.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KAE609 in people with Malaria, run by Novartis Pharmaceuticals at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Inhibitory Concentration (MIC) of KAE609 (time frame: Up to Day 8 after a single dose of KAE609). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.