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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 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

56

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Storbritannien
      • Leeds, Storbritannien, LS2 9LH
        • Covance Clinical Research Unit

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 55 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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)
Läkemedel: AC-084
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
Placebo-jämförare: Placebo,single ascending dose (Part A)
Matched placebo administered as single ascending doses in parallel to AC-084
Läkemedel: Placebo
Placebo capsules matching AC-084 capsules
Experimentell: 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)
Läkemedel: AC-084
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
Placebo-jämförare: Placebo,multiple ascending dose (Part B)
Matched placebo administered as multiple ascending doses in parallel to AC-084
Läkemedel: Placebo
Placebo capsules matching AC-084 capsules
Experimentell: 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)
Läkemedel: AC-084
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of participants with adverse events (AEs) (Part A)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: From dosing until day 6
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
From dosing until day 6

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum plasma concentration (Cmax) following single oral ascending doses (Part A)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: From dosing until day 4
From dosing until day 4
Terminal half-life [t(1/2)] following single oral ascending doses (Part B)
Tidsram: From dosing until day 8
From dosing until day 8
Terminal half-life [t(1/2)] following single oral ascending doses (Part C)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Idorsia Pharmaceuticals Ltd.

Utredare

  • Studierektor: Martine Géhin, PhD, Actelion

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 september 2016

Primärt slutförande (Faktisk)

10 december 2017

Avslutad studie (Faktisk)

10 december 2017

Studieregistreringsdatum

Först inskickad

31 augusti 2016

Först inskickad som uppfyllde QC-kriterierna

14 september 2016

Första postat (Uppskatta)

19 september 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juli 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juli 2018

Senast verifierad

1 juli 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • AC-084-101

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