A Single Dose Study of MK-8266 (MK-8266-001)
15. oktober 2018 oppdatert av: Merck Sharp & Dohme LLC
A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8266
A three panel study, to determine if MK-8266 given as a single dose is sufficiently safe and well tolerated.
Panel A and B will consist of healthy young males and Panel C will consist of subjects with mild to moderate hypertension.
The primary hypotheses for the study are that MK-8266 given as single doses is sufficiently safe and well tolerated to permit continued clinical investigation in healthy young male volunteers and male participants with mild-to-moderate hypertension and that in males with mild to moderate hypertension, at a single oral dose of MK-8266 that is sufficiently safe and well-tolerated, postdose mean time-weighted average across 24 hours of aortic augmentation index (TWA0-12hrs AIx) is reduced compared to placebo.
A mean decrease of ≥ 5 percentage points is considered clinically meaningful.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Three panels, each consisting of either 8 or 9 participants (8 healthy young males in Panel A and Panel B; and 9 participants with mild to moderate hypertension in Panel C) will be randomized to receive either MK-8266 or matching placebo in either a 6:2 ratio (Panel A and Panel B) or 6:3 ratio (Panel C), respectively, in up to 5 treatment (1 to 5) periods in Panel A and up to 4 treatment (1 to 4) periods in Panel B and Panel C. In all panels, doses will be escalated in a rising, fixed sequence.
Some participants took study drug after fasting and some with food.
Studietype
Intervensjonell
Registrering (Faktiske)
25
Fase
- Fase 1
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- For Panel A and B Participant is a healthy male between 18 to 45 years of age. For Panel C Participant is a male with essential hypertension between 18 to 55 years of age
- A non-smoker
Exclusion Criteria:
- Has a history of stroke, chronic seizure or major neurological disorder
- Has a disability that can interfere with rising from a sitting position to the standing position
- Has a personal of family history of bleeding or clotting disorders
- Has a history of cancer
- Is unable to refrain from or anticipates the use of any prescription or nonprescription drug during the study
- Consumes excessive amounts of caffeine or alcohol
- Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Panel A, Healthy Male Participants, Sequence 1
MK-8266 in Period 1: 0.1 mg/ Period 2: 0.2 mg/ Period 3: placebo/ Period 4: 1.0 mg/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose.
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel A, Healthy Male Participants, Sequence 2
MK-8266 in Period 1: 0.1 mg/ Period 2: 0.2 mg/ Period 3: 0.5 mg/ Period 4: placebo/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose.
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel A, Healthy Male Participants, Sequence 3
MK-8266 in Period 1: 0.1 mg/ Period 2: placebo/ Period 3: 0.5/ Period 4: 1.0 mg/ Period 5: placebo.
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel A, Healthy Male Participants, Sequence 4
MK-8266 in Period 1: placebo/ Period 2: 0.2 mg/ Period 3: 0.5 mg/ Period 4: 1.0 mg/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose.
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel B, Healthy Male Participants, Sequence 1
MK-8266 in Period 1: 0.4 mg/ Period 2: 1.2 mg/ Period 3: placebo/ Period 4: 0.4 mg fed/ Period 5: na.
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel B, Healthy Male Participants, Sequence 2
MK-8266 in Period 1: 0.4 mg/ Period 2: placebo/ Period 3: 1.2 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 0.4 mg fed/ Period 5: na.
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel B, Healthy Male Participants, Sequence 3
MK-8266 in Period 1: 0.4 mg/ Period 2: 1.2 mg/ Period 3: 1.2 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 0.4 mg fed/ Period 5: na.
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel B, Healthy Male Participants, Sequence 4
MK-8266 in Period 1: placebo/ Period 2: 1.2 mg/ Period 3: 1.2 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: placebo/ Period 5: na.
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel C, Mild/Moderate Hypertension, Sequence 1
Period 1: placebo/ Period 2 1.2 mg dose followed in 8 hours by a 1.0 mg dose/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose/ Period 5: na
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel C, Mild/Moderate Hypertension, Sequence 2
Period 1: placebo/ Period 2 1.2 mg dose followed in 8 hours by a 1.0 mg dose/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: placebo/ Period 5: na
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel C, Mild/Moderate Hypertension, Sequence 3
Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2 placebo/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose/ Period 5: na
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel C, Mild/Moderate Hypertension, Sequence 4
Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2: placebo/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: placebo/ Period 5: na
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Eksperimentell: Panel C, Mild/Moderate Hypertension, Sequence 5
Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2: 1.2 mg dose followed in 8 hours by a 1.0 mg dose// Period 3: placebo/ Period 4: 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose/ Period 5: na
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
|
Placebo komparator: Panel C, Mild/Moderate Hypertension, Sequence 6
Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2: 1.2 mg dose followed in 8 hours by a 1.0 mg dose// Period 3: placebo/ Period 4: placebo/ Period 5: na
|
Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Some participants will receive study drug with food.
Andre navn:
MK-8266 1.0 mg oral capsule.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
Placebo to match MK-8266 0.1 or 1.0 mg.
Participants will fast for 8 hours prior to dosing.
There will be at least a 7- day washout period between doses for any given participant.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Experienced One or More Adverse Events
Tidsramme: Up to 14 days after administration of last dose of study drug in each study period (Up to 43 Days)
|
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Participants in Arms/Groups in which MK-8266 or placebo was administered in more than one period were counted separately for each period.
|
Up to 14 days after administration of last dose of study drug in each study period (Up to 43 Days)
|
|
Number of Participants Who Discontinued Study Drug Due to an AE
Tidsramme: Up to 43 days
|
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Participants in Arms/Groups in which MK-8266 or placebo was administered in more than one period were counted separately for each period.
|
Up to 43 days
|
|
Aortic Augmentation Index - Time-Weighted Average 0-24 Hours
Tidsramme: Predose, 1.5, 3, 12, and 24 hours postdose
|
Central ascending aortic blood pressure augmentation index (AIx) is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness.
AIx can be measured non-invasively by radial tonometry using aplanation tonometry of radial artery with the SphygmoCor Pulse Wave Analysis System Guide (SphygmoCor system).
AIx was performed at prestudy to ensure an adequate waveform can be obtained.
At each time point, a minimum of 2 AIx were completed in an attempt to obtain 2 acceptable quality assessments.
A time weighted average was calculated.
AIx was adjusted for heart rate.
A decrease in the AIx of ≥5 percentage is considered clinically meaningful.
Participants in Arms/Groups in which MK-8266 or placebo was administered in more than one period were counted separately for each period.
The 12-hour measurement was not collected (per protocol) in all periods of Panels A and B.
|
Predose, 1.5, 3, 12, and 24 hours postdose
|
|
MK-8266 Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
Tidsramme: Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose
|
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body.
AUC[0-inf] is a measure of the mean concentration levels of drug in the plasma after the dose.
AUC[0-inf] was not collected, analyzed or summarized for participants receiving placebo.
|
Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose
|
|
MK-8266 PK Parameter Observed Maximum (Peak) Plasma Concentration (Cmax)
Tidsramme: Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose
|
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
For Panel A 1.0/0.8
mg MK-8266, the second dose was not well characterized due to limited sampling.
Observed exposure likely underestimates the true exposure.
Cmax was not collected, analyzed or summarized for participants receiving placebo.
|
Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose
|
|
MK-8266 PK Parameter Observed Time to Reach Cmax (Tmax)
Tidsramme: Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose
|
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.
Tmax was not collected, analyzed or summarized for participants receiving placebo.
|
Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose
|
|
MK-8266 PK Parameter Apparent t1/2
Tidsramme: Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose
|
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body.
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
Harmonic means +/- Pseudo standard deviations are displayed.
t1/2 was not collected, analyzed or summarized for participants receiving placebo.
|
Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effect of Food on MK-8266 PK Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24hr) Following Administration of Single Oral Doses of MK-8266 at 0.4 mg to Healthy Male Participants
Tidsramme: Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 postdose
|
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body.
AUC[0-24 hours] is a measure of the mean concentration levels of drug in the plasma after the dose.
The Fed Group was administered a high fat meal.
|
Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 postdose
|
|
Effect of Food on MK-8266 PK Parameter Cmax Following Administration of Single Oral Doses of MK-8266 at 0.4 mg to Healthy Male Participants
Tidsramme: Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose
|
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
The Fed Group was administered a high fat meal.
|
Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose
|
|
Time-Weighted Average of Heart Rate (0-12 Hours)
Tidsramme: Up to 12 hours
|
HR was measured with a validated automatic measuring device.
Time weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period.
The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Participants in Arms/Groups in which MK-8266 or placebo was administered in more than one period were counted separately for each period.
|
Up to 12 hours
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. november 2009
Primær fullføring (Faktiske)
14. mai 2010
Studiet fullført (Faktiske)
14. mai 2010
Datoer for studieregistrering
Først innsendt
3. desember 2009
Først innsendt som oppfylte QC-kriteriene
3. desember 2009
Først lagt ut (Anslag)
4. desember 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. oktober 2018
Sist bekreftet
1. oktober 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 8266-001
- MK-8266-001 (Annen identifikator: Merck protocol number)
- 2009_700 (Annen identifikator: Telerx ID)
- 2009-015774-36 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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