Tutkimus MK-8507:stä ja islatraviirista (MK-8591) terveillä aikuisilla osallistujilla (MK-8507-016)
Avoin tutkimus, jossa arvioidaan kaksisuuntaista vuorovaikutusta useiden viikoittaisten MK-8507-annosten ja islatraviirin (MK-8591) kerta-annosten välillä terveillä aikuisilla
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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskelupaikat
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Nebraska
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Lincoln, Nebraska, Yhdysvallat, 68502
- Celerion (Site 0001)
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
Aikaikkuna: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite
Aikaikkuna: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
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Maximum Concentration (Cmax) of Islatravir Metabolite
Aikaikkuna: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine Cmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite
Aikaikkuna: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the C168 of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
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Time to Maximum Concentration (Tmax) of Islatravir Metabolite
Aikaikkuna: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine the Tmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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Apparent Terminal Half-life (t1/2) of Islatravir Metabolite
Aikaikkuna: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine the t1/2 of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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AUC0-Inf of Islatravir
Aikaikkuna: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the AUC0-Inf of Islatravir. |
At designated timepoints (up to approximately 22 days)
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AUC0-168hrs of Islatravir
Aikaikkuna: At designated timepoints (up to approximately 7 days)
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Blood samples will be collected to determine the AUC0-168hrs of Islatravir. |
At designated timepoints (up to approximately 7 days)
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Cmax of Islatravir
Aikaikkuna: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine Cmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
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C168 of Islatravir
Aikaikkuna: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the C168 of Islatravir. |
At designated timepoints (up to approximately 168 hours)
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Tmax of Islatravir
Aikaikkuna: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the Tmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
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t1/2 of Islatravir
Aikaikkuna: 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)
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Apparent clearance (CL/F) of Islatravir
Aikaikkuna: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the CL/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
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Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir
Aikaikkuna: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the Vd/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
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AUC0-168hrs of MK-8507
Aikaikkuna: At designated timepoints (up to approximately 7 days)
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Blood samples will be collected to determine the AUC0-168hrs of MK-8507. |
At designated timepoints (up to approximately 7 days)
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Cmax of MK-8507
Aikaikkuna: At designated timepoints (up to approximately 15 days)
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Blood samples will be collected to determine Cmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
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C168 of MK-8507
Aikaikkuna: 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)
|
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Tmax of MK-8507
Aikaikkuna: 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)
|
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t1/2 of MK-8507
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Participants Who Experience an Adverse Event (AE)
Aikaikkuna: Up to approximately 5 months
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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
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Number of Participants Who Discontinue Study Treatment Due to an AE
Aikaikkuna: Up to approximately 5 months
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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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Medical Director, Merck Sharp & Dohme LLC
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 8507-016
- MK-8507-016 (Muu tunniste: MSD)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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