a study to evaluate antimalarial activity and safety of mk-7602 in healthy adults (mk-7602-003)

Conditions: Malaria

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.


Eligibility criteria:
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 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 exclusion criteria: * 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 * 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