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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2002-12-31

Brief Summary

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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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Detailed Description

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

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Lucerastat

Intervention Type DRUG

Hard gelatin capsule for oral administration containing lucerastat

B.i.d. Dose Group

Subjects received two doses of lucerastat (2 x 1 g) 12 hours apart on Day 1

Group Type EXPERIMENTAL

Lucerastat

Intervention Type DRUG

Hard gelatin capsule for oral administration containing lucerastat

Placebo for singe ascending doses

These subjects received matching placebo administered orally in the morning of Day 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsules

Placebo for b.i.d.Group

These subjects received matching placebo administered orally in the morning and in the evening of Day 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsules

Interventions

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Lucerastat

Hard gelatin capsule for oral administration containing lucerastat

Intervention Type DRUG

Placebo

Matching placebo capsules

Intervention Type DRUG

Other Intervention Names

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OGT-923 ACT-434964

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes