A Single Dose Study of MK-8266 (MK-8266-001)
15. října 2018 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
25
Fáze
- Fáze 1
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 55 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Mužský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Experimentální: 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.
Ostatní jména:
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.
|
|
Komparátor placeba: 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.
Ostatní jména:
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Who Experienced One or More Adverse Events
Časové okno: 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
Časové okno: 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
Časové okno: 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])
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
18. listopadu 2009
Primární dokončení (Aktuální)
14. května 2010
Dokončení studie (Aktuální)
14. května 2010
Termíny zápisu do studia
První předloženo
3. prosince 2009
První předloženo, které splnilo kritéria kontroly kvality
3. prosince 2009
První zveřejněno (Odhad)
4. prosince 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. února 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. října 2018
Naposledy ověřeno
1. října 2018
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 8266-001
- MK-8266-001 (Jiný identifikátor: Merck protocol number)
- 2009_700 (Jiný identifikátor: Telerx ID)
- 2009-015774-36 (Číslo EudraCT)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu IPD
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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