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Completed

NCT Number: NCT02944474

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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigator Site

Edinburgh, EH14 4AP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lucerastat

Drug

Capsule for oral administration containing lucerastat

Other names: OGT-923, ACT-434964, CDP923

Placebo

Drug

Placebo capsules matching lucerastat capsules

Primary outcomes

  1. Dose proportionality in lucerastat pharmacokinetics assessed by maximum plasma concentration (Cmax)

    Time frame: 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

  2. Dose proportionality in lucerastat pharmacokinetics assessed by area under the concentration-time curve (AUC)

    Time frame: 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

  3. Terminal elimination half-life (t1/2)

    Time frame: 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

  4. Food effect on lucerastat pharmacokinetics assessed by Cmax

    Time frame: 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)

  5. Food effect on lucerastat pharmacokinetics assessed by AUC

    Time frame: 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)

  6. Number of participants with adverse events (AEs)

    Time frame: 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

  7. Change from baseline in haematology after multiple doses of lucerastat

    Time frame: Up to Day 9

  8. Change from baseline in clinical chemistry after multiple doses of lucerastat

    Time frame: Up to Day 9

  9. Change from baseline in heart rate after multiple doses of lucerastat

    Time frame: Up to Day 9

Secondary outcomes

  1. Change from baseline in haematology after a single dose of lucerastat

    Time frame: At 24 hours post dose

  2. Change from baseline in clinical chemistry after a single dose of lucerastat

    Time frame: At 24 hours post dose

  3. Change from baseline in heart rate after a single dose of lucerastat

    Time frame: At 24 hours post dose

  4. Change from baseline in blood pressure after a single dose of lucerastat

    Time frame: Up to 24 hours post dose

  5. Change from baseline in electrocardiogram (ECG) variables after a single dose of lucerastat

    Time frame: Up to 24 hours post dose

  6. Stool frequency after multiple doses of lucerastat

    Time frame: Every day up to Day 9

  7. Change from baseline in body weight after multiple doses of lucerastat

    Time frame: At Day 9

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Oct 26, 2016
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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