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A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lucerastat (CDP923) After Multiple Dosing in Healthy Subjects

25. oktober 2016 opdateret af: Actelion

A Randomised Double-blind, Placebo-controlled, Ascending Multiple Dose Phase 1 Study of CDP923 in Healthy Volunteers to Assess Safety, Tolerability, Pharmacokinetics and Food Effect

The objectives of this study were to evaluate the safety and tolerability of lucerastat and to determine its pharmacokinetic profile after multiple dosing. Also, the potential effect of food on the pharmacokinetics of lucerastat was explored following a single dose of 500 mg.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The subjects were to be enrolled sequentially to three dose groups, starting with the lowest dose level. Subjects could participate in only one Group. Progression to an increased dose of lucerastat was permitted only after review of all data from the previous cohort suggested that it was safe to do so.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

37

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Signed informed consent form.
  • Male subjects aged from 18 to 45 years at screening.
  • Body weight between 50 and 100 kg and body mass index (BMI) between 18.0 and 29.0 kg/m2 at screening.
  • Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion Criteria:

  • History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments.
  • Serious adverse reaction or hypersensitivity to any drug.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1 (200 mg)
Six subjects received 200 mg of lucerastat twice daily for 7 consecutive days in fasting conditions
Medicin: Lucerastat
Capsule for oral administration containing lucerastat
Andre navne:
  • ACT-434964
  • OGT-923
  • CDP923
Eksperimentel: Cohort 2 (500 mg)
Six subjects received 500 mg of lucerastat as a single dose in the morning of Day 1 in fed conditions. After a 5-day washout, they received the same dose twice daily for 7 consecutive days in fasting conditions
Medicin: Lucerastat
Capsule for oral administration containing lucerastat
Andre navne:
  • ACT-434964
  • OGT-923
  • CDP923
Eksperimentel: Cohort 3 (500 mg)
Six subjects received 500 mg of lucerastat twice daily for 7 consecutive days in fasting conditions
Medicin: Lucerastat
Capsule for oral administration containing lucerastat
Andre navne:
  • ACT-434964
  • OGT-923
  • CDP923
Eksperimentel: Cohort 4 (1000 mg)
Six subjects received 1 g of lucerastat for 7 consecutive days in fasting conditions
Medicin: Lucerastat
Capsule for oral administration containing lucerastat
Andre navne:
  • ACT-434964
  • OGT-923
  • CDP923
Placebo komparator: Placebo cohorts 1 to 4
Twelve subjects received matched placebo (3 subjects per cohort, except for Cohort 3 where 4 subjects received placebo)
Medicin: Placebo
Placebo capsules matching lucerastat capsules

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose proportionality in lucerastat pharmacokinetics assessed by maximum plasma concentration (Cmax)
Tidsramme: PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose
Cmax was used to assess dose proportionality across all dose groups
PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose
Dose proportionality in lucerastat pharmacokinetics assessed by area under the concentration-time curve (AUC)
Tidsramme: PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
AUC from time zero to infinity [AUC(0-inf)] was used to assess dose proportionality across all dose groups
PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
Terminal elimination half-life (t1/2)
Tidsramme: PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
t1/2 was calculated from the plasma concentrations-time curves of lucerastat after multiple doses
PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
Food effect on lucerastat pharmacokinetics assessed by Cmax
Tidsramme: PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
Potential food effect on pharmacokinetic parameters of lucerastat was tested by comparing Cmax in fed vs fasted state in the 500 mg cohort (cohort 2)
PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
Food effect on lucerastat pharmacokinetics assessed by AUC
Tidsramme: PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
Potential food effect on pharmacokinetic parameters of lucerastat was tested by comparing AUC in fed versus fasted state in the 500 mg cohort (cohort 2)
PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
Number of participants with adverse events (AEs)
Tidsramme: From baseline up to Day 14 (end of study)
An AE was defined as any untoward medical occurrence in a clinical investigation subject, which did not necessarily have a causal relationship with the treatment
From baseline up to Day 14 (end of study)
Change from baseline in haematology after multiple doses of lucerastat
Tidsramme: Up to Day 9
Up to Day 9
Change from baseline in clinical chemistry after mutliple doses of lucerastat
Tidsramme: Up to Day 9
Up to Day 9
Change from baseline in heart rate after mutliple doses of lucerastat
Tidsramme: Up to Day 9
Up to Day 9

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline in haematology after a single dose of lucerastat
Tidsramme: At 24 hours post dose
At 24 hours post dose
Change from baseline in clinical chemistry after a single dose of lucerastat
Tidsramme: At 24 hours post dose
At 24 hours post dose
Change from baseline in heart rate after a single dose of lucerastat
Tidsramme: At 24 hours post dose
At 24 hours post dose
Change from baseline in blood pressure after a single dose of lucerastat
Tidsramme: Up to 24 hours post dose
Up to 24 hours post dose
Change from baseline in electrocardiogram (ECG) variables after a single dose of lucerastat
Tidsramme: Up to 24 hours post dose
Up to 24 hours post dose
Stool frequency after multiple doses of lucerastat
Tidsramme: Every day up to Day 9
Every day up to Day 9
Change from baseline in body weight after multiple doses of lucerastat
Tidsramme: At Day 9
At Day 9

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Actelion

Efterforskere

  • Nicolas Guérard, Actelion

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2003

Primær færdiggørelse (Faktiske)

1. maj 2004

Studieafslutning (Faktiske)

1. maj 2004

Datoer for studieregistrering

Først indsendt

24. oktober 2016

Først indsendt, der opfyldte QC-kriterier

25. oktober 2016

Først opslået (Skøn)

26. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CDP923-002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Lucerastat

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Albania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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