A Clinical Trial of MK-7602 in Healthy Volunteers (MK-7602-006)
A Clinical Study to Evaluate the Effect of Pyronaridine on the Pharmacokinetics of MK-7602 in Healthy Participants
MK-7602 is a new medicine that is being studied to treat malaria. Malaria is a disease caused by a parasite that spreads to people through mosquito bites. Symptoms of malaria include fever, chills, and flu-like illness. If malaria is not treated, some people can have serious problems that can be deadly.
The goal of this trial is to learn what happens to MK-7602 in a person's body over time (a pharmacokinetic or PK trial). Researchers will compare what happens to MK-7602 in people's blood when it is taken alone (Period 1) and in combination with another medicine called pyronaridine (Period 2). Researchers also want to learn about the safety of MK-7602 taken with and without pyronaridine and if people tolerate them.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Is in good health
- Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer (malignancy)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Period 1: MK-7602
Participants will receive an oral dose of MK-7602 once daily on Days 1, 2, and 3 of Period 1. |
Oral administration |
|
Eksperimentel: Period 2: MK-7602 + Pyronaridine
Participants will receive oral doses of MK-7602 and pyronaridine once daily on Days 1, 2, and 3 of Period 2. |
Oral administration Oral administration |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Curve From Time 0 to the Next Dosing Interval (AUC0-tau) of MK-7602
Tidsramme: At designated timepoints (up to approximately 21 days)
|
Blood samples will be collected to determine the AUC0-tau of MK-7602 with and without pyronaridine. |
At designated timepoints (up to approximately 21 days)
|
|
Maximum Plasma Concentration (Cmax) of MK-7602
Tidsramme: At designated timepoints (up to approximately 21 days)
|
Blood samples will be collected to determine the Cmax of MK-7602 with and without pyronaridine. |
At designated timepoints (up to approximately 21 days)
|
|
Number of Participants Who Experience an Adverse Event (AE)
Tidsramme: Up to approximately 2 months
|
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. The number of participants who experience an AE will be reported. |
Up to approximately 2 months
|
|
Number of Participants Who Discontinue Study Intervention Due to an AE
Tidsramme: Up to approximately 20 days
|
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. The number of participants who discontinue study intervention due to an AE will be reported. |
Up to approximately 20 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
AUC0-tau of MK-7602
Tidsramme: At designated timepoints (up to approximately 19 days)
|
Blood samples will be collected to determine the AUC0-tau of MK-7602 with and without pyronaridine. |
At designated timepoints (up to approximately 19 days)
|
|
Cmax of MK-7602
Tidsramme: At designated timepoints (up to approximately 19 days)
|
Blood samples will be collected to determine the Cmax of MK-7602 with and without pyronaridine. |
At designated timepoints (up to approximately 19 days)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 7602-006
- MK-7602-006 (Anden identifikator: MSD)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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