- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02155504
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP3700 in Healthy Male Subjects
29. Oktober 2014 aktualisiert von: Astellas Pharma Europe B.V.
A Phase 1, Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP3700 in Healthy Male Subjects, Including a Drug-drug Interaction Part With Itraconazole
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP3700 in healthy male subjects.
This study will also explore the effect of itraconazole (another drug) on the PK of ASP3700, as well as to evaluate the safety and tolerability of ASP3700 alone and in combination with itraconazole in healthy male subjects.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study consists of 2 parts: Part 1 is a single ascending dose study where subjects will receive either ASP3700 or matching placebo; Part 2 is a drug-drug interaction (DDI) open-label, crossover study comprised of 1 sequence with 2 investigational periods where subjects will receive ASP3700 alone and in combination with itraconazole.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
44
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Harrow, Vereinigtes Königreich, HA1 3UJ
- PAREXEL Early Phase Clinical Unit
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Männlich
Beschreibung
Inclusion Criteria:
- Subject has a body mass index range of 18.5 - 30.0 kg/m2. The subject weighs at least 50 kg.
- Subject and his female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the clinical study period and for 90 days after the final study drug administration.
- Subject must not donate sperm starting at screening and throughout the clinical study period and for 90 days after the final study drug administration.
Exclusion Criteria:
- Subject has a known or suspected hypersensitivity to ASP3700 (parts 1 and 2) or itraconazole (part 2 only) or significant adverse reactions to historical cannabinoid use or any components of the formulations used.
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma-glutamyl transaminase, total bilirubin [TBL]) above the upper limit of normal (ULN). In such a case the assessment may be repeated once (upon admission to the clinical unit).
- Subject has a history of a suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 3 months or who are at significant risk to commit suicide, as judged by the Investigator using the C-SSRS (a level of 4 or 5) at screening or upon admission to the clinical unit.
- Subject has any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or upon admission to the clinical unit.
- Subject has a pulse rate < 40 or > 90 beats per minute; mean SBP > 140 mmHg; mean DBP > 90 mmHg (vital signs measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse rate will be measured automatically) upon admission to the clinical unit.
- Subject has a mean corrected QT interval using Fridericia's formula (QTcF) interval > 430 ms at day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken.
- Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit.
- Subject has a history of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) within 3 months prior to admission to the clinical unit.
- Subject has consumed grapefruit, grapefruit-containing products or Seville orange-containing products within 72 hours prior to admission to the clinical unit.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: ASP3700 single ascending dose cohort
Part 1
|
oral
|
Placebo-Komparator: Placebo single ascending dose cohort
Part 1
|
Oral
|
Experimental: ASP3700 alone
Part 2
|
oral
|
Aktiver Komparator: ASP3700 and itraconazole
Part 2
|
oral
Oral
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Safety as assessed by adverse events (Part 1)
Zeitfenster: up to end of study visit (up to 16 days)
|
up to end of study visit (up to 16 days)
|
|
Safety as assessed by vital signs (Part 1)
Zeitfenster: up to end of study visit (up to 16 days)
|
up to end of study visit (up to 16 days)
|
|
Safety as assessed by laboratory tests (Part 1)
Zeitfenster: up to end of study visit (up to 16 days)
|
Laboratory tests includes the measurement of sex-hormone related biomarkers and exploratory renal biomarkers.
|
up to end of study visit (up to 16 days)
|
Safety as assessed by electrocardiogram (ECG) measurements (Part 1)
Zeitfenster: up to end of study visit (up to 16 days)
|
ECG measurements include routine 12-lead ECG, continuous cardiac monitoring (Holter ECG) and real-time cardiac monitoring (ECG telemetry)
|
up to end of study visit (up to 16 days)
|
Safety as assessed by Bond and Lader VAS (Part 1)
Zeitfenster: Up to Day 2
|
visual analogue scale (VAS)
|
Up to Day 2
|
Safety as assessed by C-SSRS (Part 1)
Zeitfenster: Up to end of study visit (up to 16 days)
|
Columbia - Suicide Severity Rating Scale (C-SSRS)
|
Up to end of study visit (up to 16 days)
|
Safety as assessed by ARCI-49 (Part 1)
Zeitfenster: Up to Day 2
|
Addiction Research Center Inventory (ARCI)-49 (49-item)
|
Up to Day 2
|
Pharmacokinetic parameter of itraconazole (plasma): Ctrough (Part 2)
Zeitfenster: Days 3-13
|
Concentration immediately prior to dosing at multiple dosing
|
Days 3-13
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUCinf (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Area under the concentration-time curve from time of dosing extrapolated to time infinity (AUCinf)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUCinf (%extrap) (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Percentage of AUCinf due to extrapolation from tlast to time infinity (AUCinf [%extrap])
|
Days 1-7 (period 1) and Days 1-13 (period 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUClast (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): Cmax (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Maximum concentration (Cmax)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma):λz (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Terminal elimination rate constant (λz)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): MRT (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Mean residence time (MRT)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): tlag (Part 2)
Zeitfenster: Day 1 (period 1 and 2)
|
Time prior to the time corresponding to the first measurable (nonzero) concentration (tlag)
|
Day 1 (period 1 and 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): tmax (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Time of maximum concentration (tmax)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): t1/2 (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Terminal elimination half-life (t1/2)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): Vz/F (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Apparent volume of distribution during the terminal elimination phase after extravascular dosing (Vz/F)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aelast (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Cumulative amount of study drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aeinf (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aelast% (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Percentage of study drug excreted into urine from the time of dosing up to the collection time of the last measurable concentration (Aelast%)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
|
Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aeinf% (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Percentage of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf%)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): CLR (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2)
|
Renal clearance (CLR)
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Days 1-7 (period 1) and Days 1-13 (period 2)
|
Safety as assessed by orthostatic evaluation (or blood pressure change in orthostatic challenge test) (Part 1)
Zeitfenster: Up to Day 7
|
Up to Day 7
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Composite of pharmacokinetics of ASP3700: AUCinf, AUCinf(%extrap), AUClast, Cmax, CL/F, λz, MRT, tlag, tmax, t½, Vz/F (plasma) (Part 1)
Zeitfenster: up to Day 7
|
up to Day 7
|
Title: Composite of pharmacokinetics of ASP3700: Aelast, Aeinf, Aelast%, Aeinf%, CLR (urine) (Part 1)
Zeitfenster: up to Day 7
|
up to Day 7
|
Safety as assessed by adverse events, vital signs, orthostatic evaluation, laboratory tests, ECG measurements, C-SSRS, Bond & Lader VAS, ARCI-49 (Part 2)
Zeitfenster: Days 1-7 (period 1) and Days 1-13 (period 2) and at end of study visit (up to 22 days)
|
Days 1-7 (period 1) and Days 1-13 (period 2) and at end of study visit (up to 22 days)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Mai 2014
Primärer Abschluss (Tatsächlich)
1. Oktober 2014
Studienabschluss (Tatsächlich)
1. Oktober 2014
Studienanmeldedaten
Zuerst eingereicht
28. Mai 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Juni 2014
Zuerst gepostet (Schätzen)
4. Juni 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
30. Oktober 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Oktober 2014
Zuletzt verifiziert
1. Oktober 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Enzym-Inhibitoren
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Cytochrom P-450 CYP3A-Inhibitoren
- Cytochrom-P-450-Enzym-Inhibitoren
- Hormonantagonisten
- Antimykotika
- Steroidsynthese-Inhibitoren
- 14-Alpha-Demethylase-Hemmer
- Itraconazol
Andere Studien-ID-Nummern
- 3700-CL-0001
- 2013-005018-36 (EudraCT-Nummer)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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