Healthy SubjectsPhase 1NCT02223871
Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects
A Phase 1 study testing ACT-451840:, Plasmodium falciparum-infected human erythrocytes: and Artemether 20 mg and lumefantrine 120mg combination tablet: in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Australia.
Trial summary
This was a single-center study using induced blood stage malaria infection to characterize the activity of ACT-451840 against early Plasmodium falciparum blood stage infection Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ACT-451840:, Plasmodium falciparum-infected human erythrocytes: and Artemether 20 mg and lumefantrine 120mg combination tablet:
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2014to Jul 2014
- Phase
- Phase 1
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight, minimum 50 kg, body mass index 18-32 kg/m^2.
- Certified healthy by detailed medical history and physical examination.
- Normal vital signs.
- Normal standard 12-lead electrocardiograph (ECG).
- Laboratory parameters within normal range, unless the investigator considered an abnormality to be clinically irrelevant.
- Use a double barrier method of contraception (male condom plus diaphragm or plus intrauterine device or plus hormonal contraceptive by female partner) for at least 14 days prior to the first dose of study drug until 90 days after the last dose.
- Written informed consent prior to undertaking any study procedure.
Who cannot join
- Any history of malaria.
- Traveled to or lived (>2 weeks) in a malaria-endemic country in the past 12 months or planned travel to a malaria-endemic country during the course of the study.
- Evidence of increased cardiovascular disease risk.
- History of splenectomy.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician or history of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
- Presence of current or suspected serious chronic disease.
Show all 43Show fewer
- Receiving psychiatric drugs or hospitalized within the past 5 years prior to enrollment for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
- Frequent headaches and/or migraine, recurrent nausea, and/or vomiting.
- Known inherited genetic anomaly.
- Presence of acute infectious disease or fever within the 5 days prior to study product administration.
- Evidence of acute illness within 4 weeks prior to screening.
- Significant intercurrent disease.
- Clinically significant disease or condition that might affect drug absorption, distribution or excretion.
- Any investigational product study within the 12 weeks preceding the study.
- Participation in a research study involving blood sampling greater than 450 mL/ unit of blood, or blood donation to a blood bank during the 8 weeks preceding the reference drug dose in the study.
- Subject unwilling to defer blood donations for 6 months.
- Blood donation within 1 month before inclusion.
- Medical requirement for intravenous immunoglobulin or blood transfusions.
- Previous blood transfusion.
- Symptomatic postural hypotension.
- History or presence of alcohol consumption of more than 40 g per day or drug habituation, or any prior intravenous usage of an illicit substance.
- Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
- Ingestion of poppy seeds within 24 hours of the screening blood test.
- Excessive consumption of beverages containing xanthine bases.
- Any medication within 14 days before inclusion or within 5 times the elimination half-life of the medication, vaccination within the last 28 days.
- Corticosteroids, anti-inflammatory drugs, immunomodulators or anticoagulants.
- Recent or current therapy with an antibiotic or drug with potential antimalarial activity.
- Subject who, in the judgment of the investigator, was likely to be non-compliant, or unable to cooperate because of a language problem or poor mental development; was in the exclusion period of a previous study; lived alone; who could not be contacted in case of emergency; who was directly involved in conducting the study; who had no good peripheral venous access.
- Positive result on any of the following tests: hepatitis B surface antigen, anti-hepatitis B core antibodies, anti-hepatitis C virus antibodies, anti-human immunodeficiency virus 1 and 2 antibodies.
- Amphetamine, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, tetrahydrocannabinols, tricyclic antidepressants detected in the urine drug screen unless there was an explanation acceptable to the medical investigator.
- Positive alcohol test.
- Pre-existing prolongation of the interval from beginning of the Q wave until end of the T wave corrected according to Bazett's formula (QTcB interval ) and considered clinically significant.
- Family history of sudden death, congenital prolongation of QTc interval, known congenital prolongation of QTc interval, or any clinical condition known to prolong the QTc interval. History of symptomatic cardiac arrhythmias or clinically relevant bradycardia. Electrolyte disturbances.
- ECG abnormalities at screening which in the opinion of the investigator is clinically relevant or will interfere with the ECG analysis.
- History of clinically significant ECG abnormalities.
- Known hypersensitivity to ACT-451840 or any of its excipients or artemether or other artemisinin derivatives, lumefantrine or other aryl aminoalcohols.
- Unwillingness to abstain from consumption of citrus fruits or their juices, as well as all fruit juices from admission to the end of the confinement period.
- Any history or presence of lactose intolerance.
- Ingestion of any drug since the recruitment interview (other than the doses administered in this study) which, in the opinion of the investigator, could compromise the study.
- Ingestion of any drug in the week prior to dosing or during the blood sampling period which, in the opinion of the investigator, could compromise the study.
- Failure to conform to the requirements of the protocol.
- Detection of any drug listed in the protocol in the urine drug screen unless there was an explanation acceptable to the investigator.
- Vital signs outside the reference range and clinically significant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-concept Study to Assess the Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects
This was a single-center study using induced blood stage malaria infection to characterize the activity of ACT-451840 against early Plasmodium falciparum blood stage infection
Read the detailed description
The primary objective of the study was to characterize the activity of ACT-451840 administered orally on clearance of Plasmodium falciparum blood stage parasites from the blood in healthy subjects .The inoculum used for blood stage Plasmodium falciparum challenge (BSPC) contained an estimated 1,800 viable parasite-infected erythrocytes diluted into 2 mL of normal saline for injection. Blood was collected for malaria parasitemia assessment by polymerase chain reaction (PCR). Parasitemia ≥ 1,000 parasites/mL indicated that the subjects should be treated with ACT-451840 . If PCR counts were > 5,000 parasites/mL and symptomatic they were dosed within 24 hours. Subsequent PCR blood sampling were performed prior to ACT-451840 dosing and at 2, 4, 8, 12, 16, 20, 24, 30, 36, 48, 60, 72, 84, 96, 120, 144 hours post-dosing and then approximately times per week until 2 consecutive negative samples, until Riamet® rescue treatment and at the final visit.
- Conditions
- Healthy Subjects
- Being tested
- ACT-451840:, Plasmodium falciparum-infected human erythrocytes:, Artemether 20 mg and lumefantrine 120mg combination tablet:, Primaquine:
- Keywords
- Malaria, ACT-451840
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-451840:Drug
ACT-451840 500 mg was provided in 100 mL amber glass bottles formulated as a powder for oral suspension. The ACT-451840 suspension was prepared extemporaneously by addition of 25 mL of water and administered orally under fed condition.
Plasmodium falciparum-infected human erythrocytes:Other
Each participant was inoculated on Day 0 with approximately 1,800 viable Plasmodium falciparum-infected human erythrocytes administered intravenously.
Artemether 20 mg and lumefantrine 120mg combination tablet:Drug
Also called Riamet®
Rescue treatment to ensure clearance of Plasmodium falciparum comprising six doses of four tablets (total course of 24 tablets) given over a period of 60 hours. Each dose of tablets administered orally was immediately followed by food or drinks rich in fat (e.g., milk).
Primaquine:Drug
Also called Primacin™
Rescue treatment to ensure clearance of Plasmodium falciparum, to be taken as a single oral 45 mg dose with food only if gametocytes were identified after administration of Riamet® rescue medication.
| Study group | Role | What they receive |
|---|---|---|
| ACT-451840 500 mg | Experimental | All the participants were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, all the participants received 500 mg of ACT-451840 as a single oral dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required) for all participants. Primaquine was to be administered as a single dose only in participants for whom gametocytes were still identified after administration of Riamet® rescue medication Receives: Drug: ACT-451840:; Other: Plasmodium falciparum-infected human erythrocytes:; Drug: Artemether 20 mg and lumefantrine 120mg combination tablet:; Drug: Primaquine: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a Standardized Approach
After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.
The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated using an objective standardized approach (observed data over 48 h)
Measured: 48 hours after study drug administration
Secondary outcomes (7)
Maximum Plasma Concentration (Cmax) of ACT-451840
Cmax was directly derived from the plasma concentrations-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose.
Measured: From pre-dose to 144 hours after study drug adminsitration
Time to Reach Maximum Plasma Concentration (Tmax) of ACT-451840
tmax was directly derived from the plasma concentration-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose.
Measured: From pre-dose to144 hours after study drug administration
Areas Under the Plasma Concentration-time Curve of ACT-451840
Two AUCs were calculated using non-compartmental analysis: AUC(0-t) from pre-dose to last time-point of measure and AUC(0-inf) from pre-dose and extrapolated to infinity.
Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose
Measured: From pre-dose to144 hours after study drug administration
Terminal Half-life [t(1/2)]
Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose
Measured: From pre-dose to144 hours after study drug adminsitration
Change From Baseline in Blood Pressure to End of Study (EOS)
Vital signs, including diastolic and systolic blood pressure (DBP/SBP), were measured at each outpatient visit up to 7 days after ACT-451840 administration, every day during confinement or when malaria symptoms were presented and at the end of study visit (EOS). Other measures were performed if required.
Measured: Day 28 (EOS)
Change From Baseline in Body Temperature up to End of Study (EOS)
Body temperature was measured orally
Measured: Day 28 (EOS)
Change From Baseline in Respiratory Rate to End of Study (EOS)
Measured: Day 28 (EOS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Lee, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223871
- Sponsor's protocol ID
- AC-071-102
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2014
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Marquart L, Baker M, O'Rourke P, McCarthy JS. Evaluating the pharmacodynamic effect of antimalarial drugs in clinical trials by quantitative PCR. Antimicrob Agents Chemother. 2015 Jul;59(7):4249-59. doi: 10.1128/AAC.04942-14. Epub 2015 May 11.
PubMed 25963983Krause A, Dingemanse J, Mathis A, Marquart L, Mohrle JJ, McCarthy JS. Pharmacokinetic/pharmacodynamic modelling of the antimalarial effect of Actelion-451840 in an induced blood stage malaria study in healthy subjects. Br J Clin Pharmacol. 2016 Aug;82(2):412-21. doi: 10.1111/bcp.12962. Epub 2016 May 11.
PubMed 27062080
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Study to Assess the Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02223871
- Acronym / sponsor ID
- AC-071-102
- Conditions
- Healthy Subjects
- Keywords
- Malaria, ACT-451840
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 10 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a single-center study using induced blood stage malaria infection to characterize the activity of ACT-451840 against early Plasmodium falciparum blood stage infection
Detailed description
The primary objective of the study was to characterize the activity of ACT-451840 administered orally on clearance of Plasmodium falciparum blood stage parasites from the blood in healthy subjects .The inoculum used for blood stage Plasmodium falciparum challenge (BSPC) contained an estimated 1,800 viable parasite-infected erythrocytes diluted into 2 mL of normal saline for injection. Blood was collected for malaria parasitemia assessment by polymerase chain reaction (PCR). Parasitemia ≥ 1,000 parasites/mL indicated that the subjects should be treated with ACT-451840 . If PCR counts were > 5,000 parasites/mL and symptomatic they were dosed within 24 hours. Subsequent PCR blood sampling were performed prior to ACT-451840 dosing and at 2, 4, 8, 12, 16, 20, 24, 30, 36, 48, 60, 72, 84, 96, 120, 144 hours post-dosing and then approximately times per week until 2 consecutive negative samples, until Riamet® rescue treatment and at the final visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT-451840 500 mg | Experimental | Drug: ACT-451840:, Other: Plasmodium falciparum-infected human erythrocytes:, Drug: Artemether 20 mg and lumefantrine 120mg combination tablet:, Drug: Primaquine:All the participants were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, all the participants received 500 mg of ACT-451840 as a single oral dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required) for all participants. Primaquine was to be administered as a single dose only in participants for whom gametocytes were still identified after administration of Riamet® rescue medication |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body weight, minimum 50 kg, body mass index 18-32 kg/m^2.
- Certified healthy by detailed medical history and physical examination.
- Normal vital signs.
- Normal standard 12-lead electrocardiograph (ECG).
- Laboratory parameters within normal range, unless the investigator considered an abnormality to be clinically irrelevant.
Key exclusion criteria (43 listed)
- Any history of malaria.
- Traveled to or lived (>2 weeks) in a malaria-endemic country in the past 12 months or planned travel to a malaria-endemic country during the course of the study.
- Evidence of increased cardiovascular disease risk.
- History of splenectomy.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician or history of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
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 |
|---|---|---|
| ACT-451840:ACT-451840 500 mg was provided in 100 mL amber glass bottles formulated as a powder for oral suspension. The ACT-451840 suspension was prepared extemporaneously by addition of 25 mL of water and administered orally under fed condition. | Drug | ACT-451840 500 mg |
| Plasmodium falciparum-infected human erythrocytes:Each participant was inoculated on Day 0 with approximately 1,800 viable Plasmodium falciparum-infected human erythrocytes administered intravenously. | Other | ACT-451840 500 mg |
| Artemether 20 mg and lumefantrine 120mg combination tablet:Also: Riamet®Rescue treatment to ensure clearance of Plasmodium falciparum comprising six doses of four tablets (total course of 24 tablets) given over a period of 60 hours. Each dose of tablets administered orally was immediately followed by food or drinks rich in fat (e.g., milk). | Drug | ACT-451840 500 mg |
| Primaquine:Also: Primacin™Rescue treatment to ensure clearance of Plasmodium falciparum, to be taken as a single oral 45 mg dose with food only if gametocytes were identified after administration of Riamet® rescue medication. | Drug | ACT-451840 500 mg |
Primary outcome
Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a Standardized Approach
Time frame: 48 hours after study drug administration
After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples. The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated using an objective standardized approach (observed data over 48 h)
7 secondary outcomes
Maximum Plasma Concentration (Cmax) of ACT-451840
Time frame: From pre-dose to 144 hours after study drug adminsitration
Time to Reach Maximum Plasma Concentration (Tmax) of ACT-451840
Time frame: From pre-dose to144 hours after study drug administration
Areas Under the Plasma Concentration-time Curve of ACT-451840
Time frame: From pre-dose to144 hours after study drug administration
Terminal Half-life [t(1/2)]
Time frame: From pre-dose to144 hours after study drug adminsitration
Change From Baseline in Blood Pressure to End of Study (EOS)
Time frame: Day 28 (EOS)
Change From Baseline in Body Temperature up to End of Study (EOS)
Time frame: Day 28 (EOS)
Change From Baseline in Respiratory Rate to End of Study (EOS)
Time frame: Day 28 (EOS)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25963983Marquart L, Baker M, O'Rourke P, McCarthy JS. Evaluating the pharmacodynamic effect of antimalarial drugs in clinical trials by quantitative PCR. Antimicrob Agents Chemother. 2015 Jul;59(7):4249-59. doi: 10.1128/AAC.04942-14. Epub 2015 May 11.
- Results publication: PubMed 27062080Krause A, Dingemanse J, Mathis A, Marquart L, Mohrle JJ, McCarthy JS. Pharmacokinetic/pharmacodynamic modelling of the antimalarial effect of Actelion-451840 in an induced blood stage malaria study in healthy subjects. Br J Clin Pharmacol. 2016 Aug;82(2):412-21. doi: 10.1111/bcp.12962. Epub 2016 May 11.
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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.
Michelle Lee study director
Actelion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT-451840:, Plasmodium falciparum-infected human erythrocytes: and Artemether 20 mg and lumefantrine 120mg combination tablet: in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Australia.
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 7 inclusion and 43 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 22 Aug 2019. 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 Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 10 Aug 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?
Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a Standardized Approach (time frame: 48 hours after study drug administration). 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 NCT02223871, which also lists 2 linked publications.
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 22 Aug 2019.