A Study to Evaluate if AC-084 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects
6. Juli 2018 aktualisiert von: Idorsia Pharmaceuticals Ltd.
A Three-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of AC-084 in Healthy Subjects and to Investigate the Pharmacokinetics of a Single Dose of AC-084 in Healthy CYP2C9 Poor Metabolizers
The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and well-tolerated when orally administered at single- and multiple-ascending dose to healthy adults
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The study is designed in three parts, A, B and C
Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose
Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose
Part C: single-center, open-label, single dose in CYP2C9 poor metabolizers
Studientyp
Interventionell
Einschreibung (Tatsächlich)
56
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
-
-
-
Leeds, Vereinigtes Königreich, LS2 9LH
- Covance Clinical Research 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
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Signed informed consent in the local language prior to any study-mandated procedure
- Healthy male subjects for Part A, healthy male and female subjects for Part B and Part C aged between 18 and 55 years (inclusive) at screening
- No clinically significant findings on physical examination at screening
- Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at screening
- CYP2C9 poor metabolizers (Part C)
Exclusion Criteria:
- History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed)
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
- Treatment or substances known to induce CYP enzyme drug metabolism within 30 days prior to first study treatment administration
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
- Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of their excipients
- For Part A and Part B, CYP2C9 poor metabolizers enrolled in a cohort to be dosed with single or multiple dose of 500 mg or higher of ACT-774312 (confirmed by genotyping before enrollment)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: AC-084, single ascending dose (Part A)
AC-084 administered at different single dose levels in a sequential manner, and in a maximum of 7 dose levels starting from 1 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort).
Each dose level will be investigated in a new group of at least 8 healthy male subjects (6 on active drug and 2 on placebo)
|
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
|
|
Placebo-Komparator: Placebo,single ascending dose (Part A)
Matched placebo administered as single ascending doses in parallel to AC-084
|
Placebo capsules matching AC-084 capsules
|
|
Experimental: AC-084, multiple ascending dose (Part B)
AC-084 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels.
The starting dose will be between 1 and 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A. Each dose level will be investigated in a new group of at least 8 healthy male subjects (6 on active drug and 2 on placebo)
|
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
|
|
Placebo-Komparator: Placebo,multiple ascending dose (Part B)
Matched placebo administered as multiple ascending doses in parallel to AC-084
|
Placebo capsules matching AC-084 capsules
|
|
Experimental: AC-084, single dose (Part C)
Up to 6 subjects in part C will receive AC-084 administered at a single dose (foreseen to be 100 mg)
|
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of participants with adverse events (AEs) (Part A)
Zeitfenster: From dosing until day 4
|
Treatment-emergent AEs and treatment-emergent serious AEs
|
From dosing until day 4
|
|
Number of participants with adverse events (AEs) (Part B)
Zeitfenster: From dosing until day 8
|
Treatment-emergent AEs and treatment-emergent serious AEs
|
From dosing until day 8
|
|
Number of participants with adverse events (AEs) (Part C)
Zeitfenster: From dosing until day 6
|
Treatment-emergent AEs and treatment-emergent serious AEs
|
From dosing until day 6
|
|
Incidence of safety events of interest (Part A)
Zeitfenster: From dosing until day 4
|
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
|
From dosing until day 4
|
|
Incidence of safety events of interest (Part B)
Zeitfenster: From dosing until day 8
|
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
|
From dosing until day 8
|
|
Incidence of safety events of interest (Part C)
Zeitfenster: From dosing until day 6
|
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
|
From dosing until day 6
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Maximum plasma concentration (Cmax) following single oral ascending doses (Part A)
Zeitfenster: From dosing until day 4
|
Cmax is derived from the observed plasma concentration-time curves
|
From dosing until day 4
|
|
Maximum plasma concentration (Cmax) following single oral ascending doses (Part B)
Zeitfenster: From dosing until day 8
|
Cmax is derived from the observed plasma concentration-time curves
|
From dosing until day 8
|
|
Maximum plasma concentration (Cmax) following single oral ascending doses (Part C)
Zeitfenster: From dosing until day 6
|
Cmax is derived from the observed plasma concentration-time curves
|
From dosing until day 6
|
|
Time to reach Cmax (tmax) following single oral ascending doses (Part A)
Zeitfenster: From dosing until day 4
|
Tmax is derived from the observed plasma concentration-time curves
|
From dosing until day 4
|
|
Time to reach Cmax (tmax) following single oral ascending doses (Part B)
Zeitfenster: From dosing until day 8
|
Tmax is derived from the observed plasma concentration-time curves
|
From dosing until day 8
|
|
Time to reach Cmax (tmax) following single oral ascending doses (Part C)
Zeitfenster: From dosing until day 6
|
Tmax is derived from the observed plasma concentration-time curves
|
From dosing until day 6
|
|
Terminal half-life [t(1/2)] following single oral ascending doses (Part A)
Zeitfenster: From dosing until day 4
|
From dosing until day 4
|
|
|
Terminal half-life [t(1/2)] following single oral ascending doses (Part B)
Zeitfenster: From dosing until day 8
|
From dosing until day 8
|
|
|
Terminal half-life [t(1/2)] following single oral ascending doses (Part C)
Zeitfenster: From dosing until day 6
|
From dosing until day 6
|
|
|
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part A)
Zeitfenster: From dosing until day 4
|
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
|
From dosing until day 4
|
|
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part B)
Zeitfenster: From dosing until day 8
|
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
|
From dosing until day 8
|
|
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part C)
Zeitfenster: From dosing until day 6
|
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
|
From dosing until day 6
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Martine Géhin, PhD, Actelion
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 (Tatsächlich)
12. September 2016
Primärer Abschluss (Tatsächlich)
10. Dezember 2017
Studienabschluss (Tatsächlich)
10. Dezember 2017
Studienanmeldedaten
Zuerst eingereicht
31. August 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. September 2016
Zuerst gepostet (Schätzen)
19. September 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. Juli 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Juli 2018
Zuletzt verifiziert
1. Juli 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- AC-084-101
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 .