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 luglio 2018 aggiornato da: 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
Panoramica dello studio
Descrizione dettagliata
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
Tipo di studio
Interventistico
Iscrizione (Effettivo)
56
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Leeds, Regno Unito, LS2 9LH
- Covance Clinical Research Unit
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 55 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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)
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Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
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Comparatore placebo: Placebo,single ascending dose (Part A)
Matched placebo administered as single ascending doses in parallel to AC-084
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Placebo capsules matching AC-084 capsules
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Sperimentale: 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)
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Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
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Comparatore placebo: Placebo,multiple ascending dose (Part B)
Matched placebo administered as multiple ascending doses in parallel to AC-084
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Placebo capsules matching AC-084 capsules
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Sperimentale: 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)
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Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of participants with adverse events (AEs) (Part A)
Lasso di tempo: From dosing until day 4
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Treatment-emergent AEs and treatment-emergent serious AEs
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From dosing until day 4
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Number of participants with adverse events (AEs) (Part B)
Lasso di tempo: From dosing until day 8
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Treatment-emergent AEs and treatment-emergent serious AEs
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From dosing until day 8
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Number of participants with adverse events (AEs) (Part C)
Lasso di tempo: From dosing until day 6
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Treatment-emergent AEs and treatment-emergent serious AEs
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From dosing until day 6
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Incidence of safety events of interest (Part A)
Lasso di tempo: From dosing until day 4
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Events of interest are any abnormalities in ECG, vital signs or laboratory test results
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From dosing until day 4
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Incidence of safety events of interest (Part B)
Lasso di tempo: From dosing until day 8
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Events of interest are any abnormalities in ECG, vital signs or laboratory test results
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From dosing until day 8
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Incidence of safety events of interest (Part C)
Lasso di tempo: From dosing until day 6
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Events of interest are any abnormalities in ECG, vital signs or laboratory test results
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From dosing until day 6
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Maximum plasma concentration (Cmax) following single oral ascending doses (Part A)
Lasso di tempo: From dosing until day 4
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Cmax is derived from the observed plasma concentration-time curves
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From dosing until day 4
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Maximum plasma concentration (Cmax) following single oral ascending doses (Part B)
Lasso di tempo: From dosing until day 8
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Cmax is derived from the observed plasma concentration-time curves
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From dosing until day 8
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Maximum plasma concentration (Cmax) following single oral ascending doses (Part C)
Lasso di tempo: From dosing until day 6
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Cmax is derived from the observed plasma concentration-time curves
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From dosing until day 6
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Time to reach Cmax (tmax) following single oral ascending doses (Part A)
Lasso di tempo: From dosing until day 4
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Tmax is derived from the observed plasma concentration-time curves
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From dosing until day 4
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Time to reach Cmax (tmax) following single oral ascending doses (Part B)
Lasso di tempo: From dosing until day 8
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Tmax is derived from the observed plasma concentration-time curves
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From dosing until day 8
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Time to reach Cmax (tmax) following single oral ascending doses (Part C)
Lasso di tempo: From dosing until day 6
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Tmax is derived from the observed plasma concentration-time curves
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From dosing until day 6
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Terminal half-life [t(1/2)] following single oral ascending doses (Part A)
Lasso di tempo: From dosing until day 4
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From dosing until day 4
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Terminal half-life [t(1/2)] following single oral ascending doses (Part B)
Lasso di tempo: From dosing until day 8
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From dosing until day 8
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Terminal half-life [t(1/2)] following single oral ascending doses (Part C)
Lasso di tempo: From dosing until day 6
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From dosing until day 6
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Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part A)
Lasso di tempo: From dosing until day 4
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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
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From dosing until day 4
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Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part B)
Lasso di tempo: From dosing until day 8
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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
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From dosing until day 8
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Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part C)
Lasso di tempo: From dosing until day 6
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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
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From dosing until day 6
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Martine Géhin, PhD, Actelion
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
12 settembre 2016
Completamento primario (Effettivo)
10 dicembre 2017
Completamento dello studio (Effettivo)
10 dicembre 2017
Date di iscrizione allo studio
Primo inviato
31 agosto 2016
Primo inviato che soddisfa i criteri di controllo qualità
14 settembre 2016
Primo Inserito (Stima)
19 settembre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 luglio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 luglio 2018
Ultimo verificato
1 luglio 2018
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- AC-084-101
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .