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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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 |
|
Experimental: 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Area Under the Curve From Time 0 to the Next Dosing Interval (AUC0-tau) of MK-7602
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
AUC0-tau of MK-7602
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Medical Director, Merck Sharp & Dohme LLC
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 7602-006
- MK-7602-006 (Andere Kennung: MSD)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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