A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Malaria

Treatments

Drug: Artesunate

Drug: Artemether/lumefantrine

Drug: Primaquine

Drug: MK-7602

Drug: Atovaquone/proguanil

Other: Plasmodium falciparum

Study type

Interventional

Funder types

Industry

Identifiers

NCT06294912

MK-7602-003 (Other Identifier)

7602-003

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

16 participants in 8 patient groups

Panel A: MK-7602 Single dose Part 1

Experimental group

Description:

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.

Treatment:

Drug: Atovaquone/proguanil

Other: Plasmodium falciparum

Drug: MK-7602

Drug: Primaquine

Drug: Artemether/lumefantrine

Drug: Artesunate

Panel B: MK-7602 Single dose Part 1

Experimental group

Description:

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.

Treatment:

Drug: Atovaquone/proguanil

Other: Plasmodium falciparum

Drug: MK-7602

Drug: Primaquine

Drug: Artemether/lumefantrine

Drug: Artesunate

Panel C: MK-7602 Single dose Part 1

Experimental group

Description:

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.

Treatment:

Drug: Atovaquone/proguanil

Other: Plasmodium falciparum

Drug: MK-7602

Drug: Primaquine

Drug: Artemether/lumefantrine

Drug: Artesunate

Panel D: MK-7602 Single dose Part 1

Experimental group

Description:

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.

Treatment:

Drug: Atovaquone/proguanil

Other: Plasmodium falciparum

Drug: MK-7602

Drug: Primaquine

Drug: Artemether/lumefantrine

Drug: Artesunate

Panel E: MK-7602 Single dose Part 1

Experimental group

Description:

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.

Treatment:

Drug: Atovaquone/proguanil

Other: Plasmodium falciparum

Drug: MK-7602

Drug: Primaquine

Drug: Artemether/lumefantrine

Drug: Artesunate

Panel F: MK-7602 Multiple dose Part 2

Experimental group

Description:

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.

Treatment:

Drug: Atovaquone/proguanil

Other: Plasmodium falciparum

Drug: MK-7602

Drug: Primaquine

Drug: Artemether/lumefantrine

Drug: Artesunate

Panel G: MK-7602 Multiple dose Part 2

Experimental group

Description:

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.

Treatment:

Drug: Atovaquone/proguanil

Other: Plasmodium falciparum

Drug: MK-7602

Drug: Primaquine

Drug: Artemether/lumefantrine

Drug: Artesunate

Panel H: MK-7602 Multiple dose Part 2

Experimental group

Description:

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.

Treatment:

Drug: Atovaquone/proguanil

Other: Plasmodium falciparum

Drug: MK-7602

Drug: Primaquine

Drug: Artemether/lumefantrine

Drug: Artesunate