A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lucerastat (CDP923) After Multiple Dosing in Healthy Subjects
25 oktober 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
37
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Edinburgh, Storbritannien, EH14 4AP
- Investigator site
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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 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Cohort 1 (200 mg)
Six subjects received 200 mg of lucerastat twice daily for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
Andra namn:
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Experimentell: 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
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Capsule for oral administration containing lucerastat
Andra namn:
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Experimentell: Cohort 3 (500 mg)
Six subjects received 500 mg of lucerastat twice daily for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
Andra namn:
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Experimentell: Cohort 4 (1000 mg)
Six subjects received 1 g of lucerastat for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
Andra namn:
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Placebo-jämförare: Placebo cohorts 1 to 4
Twelve subjects received matched placebo (3 subjects per cohort, except for Cohort 3 where 4 subjects received placebo)
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Placebo capsules matching lucerastat capsules
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Dose proportionality in lucerastat pharmacokinetics assessed by maximum plasma concentration (Cmax)
Tidsram: PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose
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Cmax was used to assess dose proportionality across all dose groups
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PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose
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Dose proportionality in lucerastat pharmacokinetics assessed by area under the concentration-time curve (AUC)
Tidsram: 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
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AUC from time zero to infinity [AUC(0-inf)] was used to assess dose proportionality across all dose groups
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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
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Terminal elimination half-life (t1/2)
Tidsram: 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
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t1/2 was calculated from the plasma concentrations-time curves of lucerastat after multiple doses
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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
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Food effect on lucerastat pharmacokinetics assessed by Cmax
Tidsram: PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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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)
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PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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Food effect on lucerastat pharmacokinetics assessed by AUC
Tidsram: PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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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)
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PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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Number of participants with adverse events (AEs)
Tidsram: From baseline up to Day 14 (end of study)
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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
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From baseline up to Day 14 (end of study)
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Change from baseline in haematology after multiple doses of lucerastat
Tidsram: Up to Day 9
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Up to Day 9
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Change from baseline in clinical chemistry after mutliple doses of lucerastat
Tidsram: Up to Day 9
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Up to Day 9
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Change from baseline in heart rate after mutliple doses of lucerastat
Tidsram: Up to Day 9
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Up to Day 9
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Change from baseline in haematology after a single dose of lucerastat
Tidsram: At 24 hours post dose
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At 24 hours post dose
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Change from baseline in clinical chemistry after a single dose of lucerastat
Tidsram: At 24 hours post dose
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At 24 hours post dose
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Change from baseline in heart rate after a single dose of lucerastat
Tidsram: At 24 hours post dose
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At 24 hours post dose
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Change from baseline in blood pressure after a single dose of lucerastat
Tidsram: Up to 24 hours post dose
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Up to 24 hours post dose
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Change from baseline in electrocardiogram (ECG) variables after a single dose of lucerastat
Tidsram: Up to 24 hours post dose
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Up to 24 hours post dose
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Stool frequency after multiple doses of lucerastat
Tidsram: Every day up to Day 9
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Every day up to Day 9
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Change from baseline in body weight after multiple doses of lucerastat
Tidsram: At Day 9
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At Day 9
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Nicolas Guérard, Actelion
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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
1 december 2003
Primärt slutförande (Faktisk)
1 maj 2004
Avslutad studie (Faktisk)
1 maj 2004
Studieregistreringsdatum
Först inskickad
24 oktober 2016
Först inskickad som uppfyllde QC-kriterierna
25 oktober 2016
Första postat (Uppskatta)
26 oktober 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
26 oktober 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 oktober 2016
Senast verifierad
1 oktober 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CDP923-002
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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