Eine Studie zu MK-8507 und Islatravir (MK-8591) bei gesunden erwachsenen Teilnehmern (MK-8507-016)
Eine offene Studie zur Bewertung der wechselseitigen Wechselwirkung zwischen mehreren wöchentlichen Dosen von MK-8507 und Einzeldosen von Islatravir (MK-8591) bei gesunden erwachsenen Teilnehmern
The main goals of this study are to learn what happens to Islatravir or MK-8507 in a person's body over time. Researchers will compare Islatravir given alone to Islatravir given with MK-8507. Researchers will also compare MK-8507 given alone to MK-8507 given with Islatravir.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Nebraska
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Lincoln, Nebraska, Vereinigte Staaten, 68502
- Celerion (Site 0001)
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer with protocol specified exceptions
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Islatravir+MK-8507
Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29. |
Oral administration Oral administration
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
Zeitfenster: At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite
Zeitfenster: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
|
|
Maximum Concentration (Cmax) of Islatravir Metabolite
Zeitfenster: At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine Cmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite
Zeitfenster: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
|
|
Time to Maximum Concentration (Tmax) of Islatravir Metabolite
Zeitfenster: At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine the Tmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
Apparent Terminal Half-life (t1/2) of Islatravir Metabolite
Zeitfenster: At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine the t1/2 of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
AUC0-Inf of Islatravir
Zeitfenster: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the AUC0-Inf of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
AUC0-168hrs of Islatravir
Zeitfenster: At designated timepoints (up to approximately 7 days)
|
Blood samples will be collected to determine the AUC0-168hrs of Islatravir. |
At designated timepoints (up to approximately 7 days)
|
|
Cmax of Islatravir
Zeitfenster: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine Cmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
C168 of Islatravir
Zeitfenster: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of Islatravir. |
At designated timepoints (up to approximately 168 hours)
|
|
Tmax of Islatravir
Zeitfenster: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the Tmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
t1/2 of Islatravir
Zeitfenster: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the t1/2 of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
Apparent clearance (CL/F) of Islatravir
Zeitfenster: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the CL/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir
Zeitfenster: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the Vd/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
AUC0-168hrs of MK-8507
Zeitfenster: At designated timepoints (up to approximately 7 days)
|
Blood samples will be collected to determine the AUC0-168hrs of MK-8507. |
At designated timepoints (up to approximately 7 days)
|
|
Cmax of MK-8507
Zeitfenster: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine Cmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
C168 of MK-8507
Zeitfenster: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of MK-8507. |
At designated timepoints (up to approximately 168 hours)
|
|
Tmax of MK-8507
Zeitfenster: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the Tmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
t1/2 of MK-8507
Zeitfenster: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the t1/2 of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
CL/F of MK-8507
Zeitfenster: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the CL/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
Vd/F of MK-8507
Zeitfenster: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the Vd/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Zeitfenster: Up to approximately 5 months
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. |
Up to approximately 5 months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Zeitfenster: Up to approximately 5 months
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported. |
Up to approximately 5 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Medical Director, Merck Sharp & Dohme LLC
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
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
- 8507-016
- MK-8507-016 (Andere Kennung: MSD)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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