Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-7602 · 2 trials · 2 indications
Blood samples will be collected to determine the AUC0-inf of MK-7602.
Blood samples will be collected to determine the AUC0-24hr of MK-7602.
Blood samples will be collected to determine the Cmax of MK-7602.
Blood samples will be collected to determine the Tmax of MK-7602.
Blood samples will be collected to determine the C24 of MK-7602.
Blood samples will be collected to determine the t1/2 of MK-7602.
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 |
|---|---|---|
| Part 1: MK-7602 + Efavirenz | EXPERIMENTAL | Participants will be administered MK-7602 and efavirenz. |
| Part 2, Sequence 1: Fasted→Moderate-Fat Meal→Low-Fat Meal | EXPERIMENTAL | Participants will be administered MK-7602 in the fasted state, then with a moderate-fat meal, then with a low-fat meal. |
| Part 2, Sequence 2: Fasted→Low-Fat Meal→Moderate-Fat Meal | EXPERIMENTAL | Participants will be administered MK-7602 in the fasted state, then with a low-fat meal, then with a moderate-fat meal. |
| Part 2, Sequence 3: Moderate-Fat Meal→Low-Fat Meal→Fasted | EXPERIMENTAL | Participants will be administered MK-7602 with a moderate-fat meal, then with a low-fat meal, then in the fasted state. |
| Part 2, Sequence 4: Moderate-Fat Meal→Fasted→Low-Fat Meal | EXPERIMENTAL | Participants will be administered MK-7602 with a moderate-fat meal, then in the fasted state, then with a low-fat meal. |
| Part 2, Sequence 5: Low-Fat Meal→Fasted→Moderate-Fat Meal | EXPERIMENTAL | Participants will be administered MK-7602 with a low-fat meal, then in the fasted state, then with a moderate-fat meal. |
| Part 2, Sequence 6: Low-Fat Meal→Moderate-Fat Meal→Fasted | EXPERIMENTAL | Participants will be administered MK-7602 with a low-fat meal, then with a moderate-fat meal, then in the fasted state. |
| 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 |
|---|---|---|
| MK-7602 | DRUG | Capsule |
| Efavirenz | DRUG | Tablet |
| Plasmodium falciparum | OTHER | Parasite inoculation administered by intravenous (IV) infusion as the challenge agent |
| 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. |
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Has a body-mass index (BMI) of 18 to 32 kg/m\^2. Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a history of clinically significant endocrine, gastr...
MK-7602 is an investigational small molecule being studied for the treatment of malaria. It is currently in Phase 1 clinical development, with trials conducted in healthy adults to evaluate its antimalarial activity, safety, and pharmacokinetics.
MK-7602 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and antimalarial activity in healthy adults.
MK-7602 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy adult participants.
MK-7602 has been studied in two completed Phase 1 trials. NCT06294912 evaluated antimalarial activity and safety in 16 healthy adults in Australia, and NCT06797674 assessed the effect of efavirenz on MK-7602 plasma levels in 34 healthy participants in the United States.
No alternative names for MK-7602 have been disclosed. The drug is identified solely by its development code MK-7602 in clinical trial registrations and company communications.