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

April 29, 2025 updated by: Idorsia Pharmaceuticals Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single ascending doses of lucerastat
Subjects were enrolled sequentially in 4 groups and received a single oral dose of lucerastat from 100 mg to 1000 mg in the morning of Day 1
Drug: Lucerastat
Hard gelatin capsule for oral administration containing lucerastat
Other Names:
  • ACT-434964
  • OGT-923
Experimental: B.i.d. Dose Group
Subjects received two doses of lucerastat (2 x 1 g) 12 hours apart on Day 1
Drug: Lucerastat
Hard gelatin capsule for oral administration containing lucerastat
Other Names:
  • ACT-434964
  • OGT-923
Placebo Comparator: Placebo for singe ascending doses
These subjects received matching placebo administered orally in the morning of Day 1
Drug: Placebo
Matching placebo capsules
Placebo Comparator: Placebo for b.i.d.Group
These subjects received matching placebo administered orally in the morning and in the evening of Day 1
Drug: Placebo
Matching placebo capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From baseline up to 7 days post-administration
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.
PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration
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.
PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration
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.
PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration
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.
PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration
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
PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration
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
PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration
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
PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration
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.
PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in heart rate
Time Frame: Up to 24 hours post administration
Up to 24 hours post administration
Change from baseline in blood pressure
Time Frame: Up to 24 hours post administration
Up to 24 hours post administration
Change from baseline in electrocardiogram (ECG) variables
Time Frame: Up to 24 hours post administration
Up to 24 hours post administration
Change from baseline in laboratory tests
Time Frame: Up to 24 hours post administration
Up to 24 hours post administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Idorsia Pharmaceuticals Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Idorsia Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2002

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OGT923-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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