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MK-7602

Phase 1

Malaria | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jan 13, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06294912A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)PHASE1 COMPLETED 16 — — Apr 18, 2024Jan 6, 2025Jan 13, 20251 Australia
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Study Endpoints
Primary Endpoints
Parasite reduction ratio (PRR48) (Parts 1 and 2)
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)
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)
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
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
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
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
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
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
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
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
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
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.

Secondary Endpoints
Number of Participants Who Experience an Adverse Event (AE)
Up to Day 45
Number of Participants Who Discontinue Study Intervention Due to an AE
Up to Day 13
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Panel A: MK-7602 Single dose Part 1EXPERIMENTALParticipants 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 1EXPERIMENTALParticipants 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 1EXPERIMENTALParticipants 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 1EXPERIMENTALParticipants 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 1EXPERIMENTALParticipants 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 2EXPERIMENTALParticipants 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 2EXPERIMENTALParticipants 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 2EXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
Plasmodium falciparumOTHERParasite inoculation administered by intravenous (IV) infusion as the challenge agent
MK-7602DRUGCapsules to be administered orally.
Artemether/lumefantrineDRUGTablets to be administered orally as definitive antimalarial treatment.
PrimaquineDRUGTablets to be administered orally as definitive antimalarial treatment.
ArtesunateDRUGIntravenous (IV) infusion to be administered as definitive antimalarial treatment.
Atovaquone/proguanilDRUGTablets to be administered orally as definitive antimalarial treatment.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * 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 th...

Countries:Australia
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Competitive Landscape -Malaria 8 trials
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GSK plc Sponsored ADRGSK4PHASE3Tafenoquine, Primaquine, Chloroquine, GSK3772701, RTS,S/AS01E vaccine
Novartis AG Sponsored ADRNVS1PHASE2INE963, KAE609, KLU156
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
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