- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01033318
A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)
A Double-Blind, Double Dummy, Randomized, Placebo-Controlled, Alternating Panel, Single Oral Rising Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of MK1809 in Healthy Young Volunteers
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Part 1:
- Nonsmoker for at least 6 months
- Body Mass Index (BMI) less than or equal to 29 kg/m2
- In overall good health
Part 2:
- Body Mass Index (BMI) greater than 18kg/m2 and less than or equal to 35kg/m2
- In overall good health (patients with hypertension and/or hyperlipidemia are accepted)
Exclusion Criteria:
Part 1:
- History of any cardiovascular disease or any clinically significant family history of cardiac arrhythmias or conduction abnormalities at an age less than 60 years
- History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
- History of cancer
- Clinically significant history of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
- Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
- History of asthma, severe wheezing, COPD, or other pulmonary disease
- Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties
- Major surgery, donated blood or participated in another investigational drug(s) trial within 30 days
- Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)
- Nitrate therapy within 4 weeks
- History of significant drug allergy or history of food allergies
Part 2
- History of any clinically significant cardiac or cardiovascular disease (other than hypertension)
- History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
- History of cancer
- History of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
- Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
- History of asthma, severe wheezing, COPD, or other pulmonary disease
- Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties
- Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)
- Surgery, significant blood loss, donated blood, or participated in another investigational drug(s) trial within 30 days
- Nitrate therapy within 4 weeks
- History of significant drug allergy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Part 1 A-1
Part 1; Panel A; Sequence 1: 2 mg MK1809 / placebo / 50 mg MK1809 / 150 mg MK1809 / 100 mg Losartan |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 1 A-2
Part 1; Panel A; Sequence 2: Losartan / 10 mg MK1809 / placebo / 150 mg MK1809 / 280 mg MK1809 |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 1 A-3
Part 1; Panel A; Sequence 3 2 mg MK1809 / 10 mg MK1809 / Losartan / Placebo / 280 mg MK1809
|
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 1 A-4
Part 1; Panel A; Sequence 4 2 mg MK1809 / Losartan / 50 mg MK1809 / 150 mg MK1809 / Placebo
|
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 1 A-5
Part 1; Panel A; Sequence 5: Placebo / 10 mg MK1809 / 50 mg MK1809 / Losartan / 280 mg MK1809 |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 1 B-1
Part 1; Panel B; Sequence 1: 5 mg MK1809 / Placebo / 100 mg MK1809 / 210 mg MK1809 / Placebo with food |
single oral doses of MK1809
Placebo to MK1809
|
Experimental: Part 1 B-2
Part 1; Panel B; Sequence 2: 5 mg MK1809 / 25 mg MK1809/ Placebo / Losartan / 25 mg MK1809 with food |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 1 B-3
Part 1; Panel B; Sequence 3: 5 mg MK1809 / Losartan / 100 mg MK1809 / 210 mg MK1809 / Losartan with food |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
|
Experimental: Part 1 B-4
Part 1; Panel B; Sequence 4: Losartan / 25 mg MK1809/ 100 mg MK1809 / Placebo / 25 mg MK1809 with food |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 1 B-5
Part 1; Panel B; Sequence 5: Placebo / 25 mg MK1809/ Losartan / 210 mg MK1809 / 25 mg MK1809 with food |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 2 C-1
Part 2; Panel C; Sequence 1: 50 mg MK1809 / Placebo / 150 mg MK1809 / 210 mg MK1809 / Losartan |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 2 C-2
Part 2; Panel C; Sequence 2: 50 mg MK1809 / 100 mg MK1809/ Placebo / Losartan / 280 mg MK1809 |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 2 C-3
Part 2; Panel C; Sequence 3: Losartan / 100 mg MK1809/ 150 mg MK1809 / 210 mg MK1809 / Placebo |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 2 C-4
Part 2; Panel C; Sequence 4: 50 mg MK1809 / Losartan / 150 mg MK1809 / Placebo / 280 mg MK1809 |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Experimental: Part 2 C-5
Part 2; Panel C; Sequence 5: Placebo / 100 mg MK1809/ Losartan / 210 mg MK1809 / 280 mg MK1809 |
single oral doses of MK1809
single oral doses of 100 mg Losartan
Andere Namen:
Placebo to MK1809
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state
Zeitfenster: Through 32 hours postdose
|
Through 32 hours postdose
|
Part 1: Trough plasma concentration in healthy adult male subjects in the fasted state
Zeitfenster: 24 hours postdose
|
24 hours postdose
|
Part 2: Safety and tolerability of rising single oral doses of MK1809 in adult hypertensive patients based on an assessment of clinical and laboratory adverse experiences
Zeitfenster: Duration of study and up to 14 days after administration of the last dose of study drug
|
Duration of study and up to 14 days after administration of the last dose of study drug
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Part 1: Area under the plasma concentration (AUC) versus time curve resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state)
Zeitfenster: 24 hours postdose
|
24 hours postdose
|
Part 1: Maximum concentration of drug in the plasma (Cmax) resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state)
Zeitfenster: Through 32 hours postdose
|
Through 32 hours postdose
|
Part 1: Number of clinical and laboratory adverse experiences (AEs) to assess safety and tolerability
Zeitfenster: Duration of study and up to 14 days after administration of the last dose of study drug
|
Duration of study and up to 14 days after administration of the last dose of study drug
|
Part 2: Area under the plasma concentration (AUC) versus time curve of the E3174 metabolite
Zeitfenster: Through 32 hours postdose
|
Through 32 hours postdose
|
Part 2: Trough plasma concentration of the E3174 metabolite
Zeitfenster: Through 32 hours postdose
|
Through 32 hours postdose
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1809-001
- MK1809-001
- 2009_703
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