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Completed

NCT Number: NCT02944487

A Study to Assess the Safety and Pharmacokinetics of Lucerastat (OGT 923) in Healthy Subjects

The objectives of this study were to evaluate the safety and tolerability of lucerastat, and to determine its pharmacokinetic profile as single oral doses at different strengths.

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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

Tranent, EH33 2NE, United Kingdom

About this study

The subjects were enrolled sequentially to five dose groups, starting with the lowest dose level. Subjects could participate in only one Group.

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

Hard gelatin capsule for oral administration containing lucerastat

Other names: OGT-923, ACT-434964

Placebo

Drug

Matching placebo capsules

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: From baseline up to 7 days post-administration

    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.

  2. Maximum plasma concentration (Cmax) of lucerastat after single ascending doses of lucerastat

    Time frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration

    Cmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving a single dose.

  3. Maximum plasma concentration (Cmax) of lucerastat after two daily doses of lucerastat

    Time frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration

    Cmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving lucerastat twice daily.

  4. Time to reach Cmax (tmax) of lucerastat after single ascending doses of lucerastat

    Time frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration

    tmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving a single dose.

  5. Time to reach Cmax (tmax) of lucerastat after two daily doses of lucerastat

    Time frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration

    tmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving lucerastat twice daily.

  6. Area under the plasma concentration-time curves (AUC) of lucerastat after single ascending doses of lucerastat

    Time frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration

    AUC was calculated from time zero to time t (last PK blood sample in which drug was detected) and extrapolated to infinity for subjects receiving a single dose.

  7. Area under the plasma concentration-time curves (AUC) of lucerastat after two daily doses of lucerastat

    Time frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration

    AUC was calculated from time zero to time t (last PK blood sample in which drug was detected) and extrapolated to infinity for subjects receiving lucerastat twice daily

  8. Terminal elimination half-life (t1/2) of lucerastat after single ascending doses of lucerastat

    Time frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration

    t1/2 was calculated from the corresponding plasma concentrations-time curves for subjects receiving a single dose

  9. Terminal elimination half-life (t1/2) of lucerastat after two daily doses of lucerastat

    Time frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration

    t1/2 was calculated from the plasma concentrations-time curves for subjects receiving lucerastat twice daily

Secondary outcomes

  1. Change from baseline in heart rate

    Time frame: Up to 24 hours post administration

  2. Change from baseline in blood pressure

    Time frame: Up to 24 hours post administration

  3. Change from baseline in electrocardiogram (ECG) variables

    Time frame: Up to 24 hours post administration

  4. Change from baseline in laboratory tests

    Time frame: Up to 24 hours post administration

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled Ascending Dose Tolerance Study of OGT 923 in Healthy Male Volunteers

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Oct 26, 2016
Registry last updated
May 1, 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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