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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06294912




Registration number
NCT06294912
Ethics application status
Date submitted
28/02/2024
Date registered
6/03/2024
Date last updated
27/06/2024

Titles & IDs
Public title
A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)
Scientific title
A Controlled Human Malaria Infection Study to Evaluate the Antimalarial Activity of MK-7602 Against Plasmodium Falciparum Blood Stage Infection in Healthy Adult Participants
Secondary ID [1] 0 0
MK-7602-003
Secondary ID [2] 0 0
7602-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Plasmodium falciparum
Treatment: Drugs - MK-7602
Treatment: Drugs - Artemether/lumefantrine
Treatment: Drugs - Primaquine
Treatment: Drugs - Artesunate
Treatment: Drugs - Atovaquone/proguanil

Experimental: Panel A: MK-7602 Single dose Part 1 - 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.

Experimental: Panel B: MK-7602 Single dose Part 1 - 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.

Experimental: Panel C: MK-7602 Single dose Part 1 - 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.

Experimental: Panel D: MK-7602 Single dose Part 1 - 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.

Experimental: Panel E: MK-7602 Single dose Part 1 - 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.

Experimental: Panel F: MK-7602 Multiple dose Part 2 - 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.

Experimental: Panel G: MK-7602 Multiple dose Part 2 - 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.

Experimental: Panel H: MK-7602 Multiple dose Part 2 - 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.


Other interventions: Plasmodium falciparum
Parasite inoculation administered by intravenous (IV) infusion as the challenge agent

Treatment: Drugs: MK-7602
Capsules to be administered orally.

Treatment: Drugs: Artemether/lumefantrine
Tablets to be administered orally as definitive antimalarial treatment.

Treatment: Drugs: Primaquine
Tablets to be administered orally as definitive antimalarial treatment.

Treatment: Drugs: Artesunate
Intravenous (IV) infusion to be administered as definitive antimalarial treatment.

Treatment: Drugs: Atovaquone/proguanil
Tablets to be administered orally as definitive antimalarial treatment.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Parasite reduction ratio (PRR48) (Parts 1 and 2)
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Parasite Clearance Half-life (PCt1/2) (Parts 1 and 2)
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
Parasite Regrowth (Parts 1 and 2)
Timepoint [3] 0 0
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
Primary outcome [4] 0 0
Part 1 Single dose: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of MK-7602
Timepoint [4] 0 0
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
Primary outcome [5] 0 0
Part 1 Single dose: Maximum Plasma Concentration (Cmax) of MK-7602
Timepoint [5] 0 0
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
Primary outcome [6] 0 0
Part 1 Single dose: Concentration at 24 Hours (C24) of MK-7602
Timepoint [6] 0 0
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
Primary outcome [7] 0 0
Part 1 Single dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602
Timepoint [7] 0 0
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
Primary outcome [8] 0 0
Part 1 Single dose: Elimination Half-life (t1/2) of MK-7602
Timepoint [8] 0 0
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
Primary outcome [9] 0 0
Part 2 Multiple dose: Area Under the Curve Time 0 to End of the Dosing Interval (AUC0-tau) of MK-7602
Timepoint [9] 0 0
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
Primary outcome [10] 0 0
Part 2 Multiple dose: Maximum Plasma Concentration (Cmax) of MK-7602
Timepoint [10] 0 0
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
Primary outcome [11] 0 0
Part 2 Multiple dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602
Timepoint [11] 0 0
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
Primary outcome [12] 0 0
Part 2 Multiple dose: Elimination Half-life (t1/2) of MK-7602
Timepoint [12] 0 0
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
Secondary outcome [1] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [1] 0 0
Up to Day 45
Secondary outcome [2] 0 0
Number of Participants Who Discontinue Study Intervention Due to an AE
Timepoint [2] 0 0
Up to Day 13

Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:



* 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/03/2025
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
USC Clinical Trials Brisbane (South Bank) ( Site 0001) - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06294912
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@merck.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06294912