Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-7602 · 1 trial · 1 indication
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.
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 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.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the AUC0-inf for Part 1.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Cmax for Part 1.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the C24 for Part 1.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Tmax for Part 1.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the t1/2 for Part 1.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the AUC0-tau for Part 2.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Cmax for Part 2.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the Tmax for Part 2.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine the t½ for Part 2.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Plasmodium falciparum | OTHER | Parasite inoculation administered by intravenous (IV) infusion as the challenge agent |
| MK-7602 | DRUG | Capsules to be administered orally. |
| Artemether/lumefantrine | DRUG | Tablets to be administered orally as definitive antimalarial treatment. |
| Primaquine | DRUG | Tablets to be administered orally as definitive antimalarial treatment. |
| Artesunate | DRUG | Intravenous (IV) infusion to be administered as definitive antimalarial treatment. |
| Atovaquone/proguanil | DRUG | Tablets to be administered orally as definitive antimalarial treatment. |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 4 | PHASE3 | Tafenoquine, GSK3772701, Mosquirix, GSK4425689A |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
MK-7602 is an investigational small molecule drug being developed by Merck & Company, Inc. for the treatment of malaria. It is in Phase 1 clinical development and has been studied in a controlled trial in healthy adult volunteers. It is not approved for any use.
MK-7602 is being developed for malaria, an infectious disease. The clinical work completed to date evaluated its antimalarial activity and safety in healthy adults rather than in patients with confirmed malaria infection. It remains investigational and is not approved for treating malaria or any other condition.
MK-7602 is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program studying the compound in malaria.
MK-7602 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently listed as active. The program remains investigational, and MK-7602 has not been approved by the FDA or any other regulatory agency for malaria or any other indication.
MK-7602 has been studied in one completed Phase 1 trial, NCT06294912, titled A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003). It enrolled 16 healthy adult volunteers in Australia, was randomized and controlled, and included participants of all sexes aged 18 years and older.