MalariaPhase 1NCT06294912
A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)
A Phase 1 study testing Plasmodium falciparum, MK-7602 and Artemether/lumefantrine in people with Malaria, run by Merck Sharp & Dohme LLC at 1 site in Australia.
Trial summary
The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Plasmodium falciparum, MK-7602 and Artemether/lumefantrine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Apr 2024to 6 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good health
- Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive
- For participant assigned male sex at birth: If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 90 days after the last dose of MK-7602: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom plus additional contraceptive method
- For participant assigned female sex at birth: EITHER be a person of nonchildbearing potential (PONCBP) OR must use a highly effective contraceptive method or be abstinent during the intervention period and for at least 10 days after the last dose of study intervention
- Must provide confirmation of not living alone (at any stage from inoculation day until the end of the study). A participant who lives alone may be included on a case-by-case basis.
- Agrees to refrain from eating food containing poppy seeds for 48 hours prior to screening, malaria inoculation, and MK-7602 administration
Who cannot join
- History of clinically significant clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Is mentally or legally incapacitated or has a history of clinically significant psychiatric disorder
- History of cancer (malignancy)
- History of malaria
- History of splenectomy
- History of ever receiving a blood transfusion
Show all 19Show fewer
- History of recurrent headache (eg, tension-type, cluster or migraine) with a frequency of ≥2 episodes per month on average and severe enough to require medical therapy, during the 5 years preceding the screening visit
- History of convulsion (including intravenous drug or vaccine-induced episodes). A medical history of a single febrile convulsion during childhood is not considered an exclusion criterion.
- Has presence of clinically significant infectious disease or fever (eg, sublingual temperature ≥38.5 degrees Celsius) within the 5 days prior to inoculation
- Has evidence of acute illness within the 4 weeks prior to screening that the Investigator deems may compromise participant safety
- Has clinically significant disease or any condition or disease that might affect drug absorption, distribution, or excretion (eg, gastrectomy, diarrhea)
- Has a medical requirement for intravenous immunoglobulin or blood transfusions
- Has had a major surgery with more than 470 mL of blood loss, lost 1 unit of blood (approximately 470 mL) or undergone blood donation of any volume to the Australian Red Cross Blood Service (Blood Service) or other blood blank within 4 weeks prior to the prestudy screening visit) or during the 8 weeks prior to inoculation
- Has used any corticosteroids, anti-inflammatory drugs (excluding commonly used over-the-counter anti-inflammatory drugs such as ibuprofen, acetylsalicylic acid, diclofenac), immunomodulators or anticoagulants within the past three months
- History of receiving immunosuppressive therapy (including systemic steroids, adrenocorticotrophic hormone, or inhaled steroids) at a dose or duration potentially associated with hypothalamic-pituitary-adrenal axis suppression within the past year from the screening visit
- Has had any vaccination within the last 28 days
- Has participated in another investigational study within 12 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit
- History of participation in a previous malaria challenge study or malaria vaccine study.
- Must not have had malaria exposure that is considered by the principal investigator or their delegate to be significant
Trial locations and contacts
1 site in 1 country.
Australia1 site
USC Clinical Trials Brisbane (South Bank) ( Site 0001)
South Brisbane, South Australia, 4101
About this study
Official title: A Controlled Human Malaria Infection Study to Evaluate the Antimalarial Activity of MK-7602 Against Plasmodium Falciparum Blood Stage Infection in Healthy Adult Participants
The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection.
- Conditions
- Malaria
- Being tested
- Plasmodium falciparum, MK-7602, Artemether/lumefantrine, Primaquine, Artesunate
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmodium falciparumOther
Also called P. falciparum
Parasite inoculation administered by intravenous (IV) infusion as the challenge agent
MK-7602Drug
Capsules to be administered orally.
Artemether/lumefantrineDrug
Also called Riamet®; Coartem®
Tablets to be administered orally as definitive antimalarial treatment.
PrimaquineDrug
Also called Primacin®
Tablets to be administered orally as definitive antimalarial treatment.
ArtesunateDrug
Intravenous (IV) infusion to be administered as definitive antimalarial treatment.
Atovaquone/proguanilDrug
Also called Malarone ®
Tablets to be administered orally as definitive antimalarial treatment.
| Study group | Role | What they receive |
|---|---|---|
| Panel A: MK-7602 Single dose Part 1 | Experimental | Participants are inoculated with Plasmodium falciparum (P. falciparum). Panel A participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. Receives: Other: Plasmodium falciparum; Drug: MK-7602; Drug: Artemether/lumefantrine; Drug: Primaquine; Drug: Artesunate; Drug: Atovaquone/proguanil |
| Panel B: MK-7602 Single dose Part 1 | Experimental | Participants are inoculated with P. falciparum. Panel B participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. Receives: Other: Plasmodium falciparum; Drug: MK-7602; Drug: Artemether/lumefantrine; Drug: Primaquine; Drug: Artesunate; Drug: Atovaquone/proguanil |
| Panel C: MK-7602 Single dose Part 1 | Experimental | Participants are inoculated with P. falciparum. Panel C participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. Receives: Other: Plasmodium falciparum; Drug: MK-7602; Drug: Artemether/lumefantrine; Drug: Primaquine; Drug: Artesunate; Drug: Atovaquone/proguanil |
| Panel D: MK-7602 Single dose Part 1 | Experimental | Participants are inoculated with P. falciparum. Panel D participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. Receives: Other: Plasmodium falciparum; Drug: MK-7602; Drug: Artemether/lumefantrine; Drug: Primaquine; Drug: Artesunate; Drug: Atovaquone/proguanil |
| Panel E: MK-7602 Single dose Part 1 | Experimental | Participants are inoculated with P. falciparum. Panel E participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. Receives: Other: Plasmodium falciparum; Drug: MK-7602; Drug: Artemether/lumefantrine; Drug: Primaquine; Drug: Artesunate; Drug: Atovaquone/proguanil |
| Panel F: MK-7602 Multiple dose Part 2 | Experimental | Participants are inoculated with P. falciparum. Panel F participants receive MK-7602 at multiple oral doses. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. Receives: Other: Plasmodium falciparum; Drug: MK-7602; Drug: Artemether/lumefantrine; Drug: Primaquine; Drug: Artesunate; Drug: Atovaquone/proguanil |
| Panel G: MK-7602 Multiple dose Part 2 | Experimental | Participants are inoculated with P. falciparum. Panel G participants receive MK-7602 at multiple oral doses. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. Receives: Other: Plasmodium falciparum; Drug: MK-7602; Drug: Artemether/lumefantrine; Drug: Primaquine; Drug: Artesunate; Drug: Atovaquone/proguanil |
| Panel H: MK-7602 Multiple dose Part 2 | Experimental | Participants are inoculated with P. falciparum. Panel H participants receive MK-7602 at multiple oral doses. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. Receives: Other: Plasmodium falciparum; Drug: MK-7602; Drug: Artemether/lumefantrine; Drug: Primaquine; Drug: Artesunate; Drug: Atovaquone/proguanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite reduction ratio (PRR48) (Parts 1 and 2)
PRR48 is the logarithm of the parasite reduction ratio per 48 hours determined from parasitemia data from time 0 to time 48 hours. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the PRR48.
Measured: Pre-inoculation on Day 0, once daily Days 4 to 7, pre-dose of MK-7602 on Day 8, post-first dose of MK-7602 at 2, 4, 8, 12, 16, 24, 30, 36, 48, 54, 60, 72, (78 Part 2 only), 84, and 96 hours, and once daily Days 13, 15, 17, 20, 22, 24, 27, 29, 31, and 34
Parasite Clearance Half-life (PCt1/2) (Parts 1 and 2)
PCt1/2 is the half-life of the log-linear portion of the parasite clearance curve. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the PCt1/2.
Measured: Pre-inoculation on Day 0, once daily Days 4 to 7, pre-dose of MK-7602 on Day 8, post-first dose of MK-7602 at 2, 4, 8, 12, 16, 24, 30, 36, 48, 54, 60, 72, (78 Part 2 only), 84, and 96 hours, and once daily Days 13, 15, 17, 20, 22, 24, 27, 29, 31, and 34
Parasite Regrowth (Parts 1 and 2)
Parasite regrowth is defined as initial parasite clearance followed by asexual parasite regrowth above 5,000 parasites/mL. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the parasite regrowth.
Measured: Pre-inoculation on Day 0, once daily Days 4 to 7, pre-dose of MK-7602 on Day 8, post-first dose of MK-7602 at 2, 4, 8, 12, 16, 24, 30, 36, 48, 54, 60, 72, (78 Part 2 only), 84, and 96 hours, and once daily Days 13, 15, 17, 20, 22, 24, 27, 29, 31, and 34
Part 1 Single dose: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of MK-7602
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the AUC0-inf for Part 1.
Measured: Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Part 1 Single dose: Maximum Plasma Concentration (Cmax) of MK-7602
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Cmax for Part 1.
Measured: Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Part 1 Single dose: Concentration at 24 Hours (C24) of MK-7602
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the C24 for Part 1.
Measured: Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Part 1 Single dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Tmax for Part 1.
Measured: Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Part 1 Single dose: Elimination Half-life (t1/2) of MK-7602
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the t1/2 for Part 1.
Measured: Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Part 2 Multiple dose: Area Under the Curve Time 0 to End of the Dosing Interval (AUC0-tau) of MK-7602
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the AUC0-tau for Part 2.
Measured: Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Part 2 Multiple dose: Maximum Plasma Concentration (Cmax) of MK-7602
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Cmax for Part 2.
Measured: Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Part 2 Multiple dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Tmax for Part 2.
Measured: Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Part 2 Multiple dose: Elimination Half-life (t1/2) of MK-7602
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the t½ for Part 2.
Measured: Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Secondary outcomes (2)
Number of Participants Who Experience an Adverse Event (AE)
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
Measured: Up to Day 45
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.
Measured: Up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start18 Apr 2024
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294912
- Sponsor's protocol ID
- 7602-003
- Other IDs
- MK-7602-003
- Status last verified
- Jan 2025
- First submitted
- 28 Feb 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Human Malaria Infection Study to Evaluate the Antimalarial Activity of MK-7602 Against Plasmodium Falciparum Blood Stage Infection in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06294912
- Acronym / sponsor ID
- 7602-003
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Panel A: MK-7602 Single dose Part 1 | Experimental | Other: Plasmodium falciparum, Drug: MK-7602, Drug: Artemether/lumefantrine, Drug: Primaquine, Drug: Artesunate, Drug: Atovaquone/proguanilParticipants are inoculated with Plasmodium falciparum (P. falciparum). Panel A participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. |
| Panel B: MK-7602 Single dose Part 1 | Experimental | Other: Plasmodium falciparum, Drug: MK-7602, Drug: Artemether/lumefantrine, Drug: Primaquine, Drug: Artesunate, Drug: Atovaquone/proguanilParticipants are inoculated with P. falciparum. Panel B participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. |
| Panel C: MK-7602 Single dose Part 1 | Experimental | Other: Plasmodium falciparum, Drug: MK-7602, Drug: Artemether/lumefantrine, Drug: Primaquine, Drug: Artesunate, Drug: Atovaquone/proguanilParticipants are inoculated with P. falciparum. Panel C participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. |
| Panel D: MK-7602 Single dose Part 1 | Experimental | Other: Plasmodium falciparum, Drug: MK-7602, Drug: Artemether/lumefantrine, Drug: Primaquine, Drug: Artesunate, Drug: Atovaquone/proguanilParticipants are inoculated with P. falciparum. Panel D participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. |
| Panel E: MK-7602 Single dose Part 1 | Experimental | Other: Plasmodium falciparum, Drug: MK-7602, Drug: Artemether/lumefantrine, Drug: Primaquine, Drug: Artesunate, Drug: Atovaquone/proguanilParticipants are inoculated with P. falciparum. Panel E participants receive MK-7602 as a single oral dose. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. |
| Panel F: MK-7602 Multiple dose Part 2 | Experimental | Other: Plasmodium falciparum, Drug: MK-7602, Drug: Artemether/lumefantrine, Drug: Primaquine, Drug: Artesunate, Drug: Atovaquone/proguanilParticipants are inoculated with P. falciparum. Panel F participants receive MK-7602 at multiple oral doses. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. |
| Panel G: MK-7602 Multiple dose Part 2 | Experimental | Other: Plasmodium falciparum, Drug: MK-7602, Drug: Artemether/lumefantrine, Drug: Primaquine, Drug: Artesunate, Drug: Atovaquone/proguanilParticipants are inoculated with P. falciparum. Panel G participants receive MK-7602 at multiple oral doses. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. |
| Panel H: MK-7602 Multiple dose Part 2 | Experimental | Other: Plasmodium falciparum, Drug: MK-7602, Drug: Artemether/lumefantrine, Drug: Primaquine, Drug: Artesunate, Drug: Atovaquone/proguanilParticipants are inoculated with P. falciparum. Panel H participants receive MK-7602 at multiple oral doses. Participants will receive artemether/lumefantrine oral tablets as definitive antimalarial treatment. Additional definitive antimalarial treatment may be administered at the investigator's discretion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Is in good health
- Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive
- For participant assigned male sex at birth: If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 90 days after the last dose of MK-7602: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom plus additional contraceptive method
- For participant assigned female sex at birth: EITHER be a person of nonchildbearing potential (PONCBP) OR must use a highly effective contraceptive method or be abstinent during the intervention period and for at least 10 days after the last dose of study intervention
- Must provide confirmation of not living alone (at any stage from inoculation day until the end of the study). A participant who lives alone may be included on a case-by-case basis.
Key exclusion criteria (19 listed)
- History of clinically significant clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Is mentally or legally incapacitated or has a history of clinically significant psychiatric disorder
- History of cancer (malignancy)
- History of malaria
- History of splenectomy
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 |
|---|---|---|
| Plasmodium falciparumAlso: P. falciparumParasite inoculation administered by intravenous (IV) infusion as the challenge agent | Other | Panel A: MK-7602 Single dose Part 1, Panel B: MK-7602 Single dose Part 1, Panel C: MK-7602 Single dose Part 1, Panel D: MK-7602 Single dose Part 1, Panel E: MK-7602 Single dose Part 1, Panel F: MK-7602 Multiple dose Part 2, Panel G: MK-7602 Multiple dose Part 2, Panel H: MK-7602 Multiple dose Part 2 |
| MK-7602Capsules to be administered orally. | Drug | Panel A: MK-7602 Single dose Part 1, Panel B: MK-7602 Single dose Part 1, Panel C: MK-7602 Single dose Part 1, Panel D: MK-7602 Single dose Part 1, Panel E: MK-7602 Single dose Part 1, Panel F: MK-7602 Multiple dose Part 2, Panel G: MK-7602 Multiple dose Part 2, Panel H: MK-7602 Multiple dose Part 2 |
| Artemether/lumefantrineAlso: Riamet®; Coartem®Tablets to be administered orally as definitive antimalarial treatment. | Drug | Panel A: MK-7602 Single dose Part 1, Panel B: MK-7602 Single dose Part 1, Panel C: MK-7602 Single dose Part 1, Panel D: MK-7602 Single dose Part 1, Panel E: MK-7602 Single dose Part 1, Panel F: MK-7602 Multiple dose Part 2, Panel G: MK-7602 Multiple dose Part 2, Panel H: MK-7602 Multiple dose Part 2 |
| PrimaquineAlso: Primacin®Tablets to be administered orally as definitive antimalarial treatment. | Drug | Panel A: MK-7602 Single dose Part 1, Panel B: MK-7602 Single dose Part 1, Panel C: MK-7602 Single dose Part 1, Panel D: MK-7602 Single dose Part 1, Panel E: MK-7602 Single dose Part 1, Panel F: MK-7602 Multiple dose Part 2, Panel G: MK-7602 Multiple dose Part 2, Panel H: MK-7602 Multiple dose Part 2 |
| ArtesunateIntravenous (IV) infusion to be administered as definitive antimalarial treatment. | Drug | Panel A: MK-7602 Single dose Part 1, Panel B: MK-7602 Single dose Part 1, Panel C: MK-7602 Single dose Part 1, Panel D: MK-7602 Single dose Part 1, Panel E: MK-7602 Single dose Part 1, Panel F: MK-7602 Multiple dose Part 2, Panel G: MK-7602 Multiple dose Part 2, Panel H: MK-7602 Multiple dose Part 2 |
| Atovaquone/proguanilAlso: Malarone ®Tablets to be administered orally as definitive antimalarial treatment. | Drug | Panel A: MK-7602 Single dose Part 1, Panel B: MK-7602 Single dose Part 1, Panel C: MK-7602 Single dose Part 1, Panel D: MK-7602 Single dose Part 1, Panel E: MK-7602 Single dose Part 1, Panel F: MK-7602 Multiple dose Part 2, Panel G: MK-7602 Multiple dose Part 2, Panel H: MK-7602 Multiple dose Part 2 |
Primary outcome
Parasite reduction ratio (PRR48) (Parts 1 and 2)
Time frame: Pre-inoculation on Day 0, once daily Days 4 to 7, pre-dose of MK-7602 on Day 8, post-first dose of MK-7602 at 2, 4, 8, 12, 16, 24, 30, 36, 48, 54, 60, 72, (78 Part 2 only), 84, and 96 hours, and once daily Days 13, 15, 17, 20, 22, 24, 27, 29, 31, and 34
PRR48 is the logarithm of the parasite reduction ratio per 48 hours determined from parasitemia data from time 0 to time 48 hours. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the PRR48.
Parasite Clearance Half-life (PCt1/2) (Parts 1 and 2)
Time frame: Pre-inoculation on Day 0, once daily Days 4 to 7, pre-dose of MK-7602 on Day 8, post-first dose of MK-7602 at 2, 4, 8, 12, 16, 24, 30, 36, 48, 54, 60, 72, (78 Part 2 only), 84, and 96 hours, and once daily Days 13, 15, 17, 20, 22, 24, 27, 29, 31, and 34
PCt1/2 is the half-life of the log-linear portion of the parasite clearance curve. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the PCt1/2.
Parasite Regrowth (Parts 1 and 2)
Time frame: Pre-inoculation on Day 0, once daily Days 4 to 7, pre-dose of MK-7602 on Day 8, post-first dose of MK-7602 at 2, 4, 8, 12, 16, 24, 30, 36, 48, 54, 60, 72, (78 Part 2 only), 84, and 96 hours, and once daily Days 13, 15, 17, 20, 22, 24, 27, 29, 31, and 34
Parasite regrowth is defined as initial parasite clearance followed by asexual parasite regrowth above 5,000 parasites/mL. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the parasite regrowth.
Part 1 Single dose: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of MK-7602
Time frame: Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the AUC0-inf for Part 1.
Part 1 Single dose: Maximum Plasma Concentration (Cmax) of MK-7602
Time frame: Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Cmax for Part 1.
Part 1 Single dose: Concentration at 24 Hours (C24) of MK-7602
Time frame: Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the C24 for Part 1.
Part 1 Single dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602
Time frame: Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Tmax for Part 1.
Part 1 Single dose: Elimination Half-life (t1/2) of MK-7602
Time frame: Pre-dose of MK-7602 on Day 8 and post-dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the t1/2 for Part 1.
Part 2 Multiple dose: Area Under the Curve Time 0 to End of the Dosing Interval (AUC0-tau) of MK-7602
Time frame: Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the AUC0-tau for Part 2.
Part 2 Multiple dose: Maximum Plasma Concentration (Cmax) of MK-7602
Time frame: Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Cmax for Part 2.
Part 2 Multiple dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602
Time frame: Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Tmax for Part 2.
Part 2 Multiple dose: Elimination Half-life (t1/2) of MK-7602
Time frame: Pre-dose of MK-7602 on Day 8 and post-first dose of MK-7602 at 0.5, 1, 2, 3, 4, 8, 12, 24, 30, 36, 48, 54, 60, 72, 78, 84 and 96 hours and then once daily on Days 13, 15, 17, 20, and 22
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the t½ for Part 2.
2 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to Day 45
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to Day 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
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 Plasmodium falciparum, MK-7602 and Artemether/lumefantrine in people with Malaria, run by Merck Sharp & Dohme LLC 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 6 inclusion and 19 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 13 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Parasite reduction ratio (PRR48) (Parts 1 and 2) (time frame: Pre-inoculation on Day 0, once daily Days 4 to 7, pre-dose of MK-7602 on Day 8, post-first dose of MK-7602 at 2, 4, 8, 12, 16, 24, 30, 36, 48, 54, 60, 72, (78 Part 2 only), 84, and 96 hours, and once daily Days 13, 15, 17, 20, 22, 24, 27, 29, 31, and 34). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.