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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2004-05-31

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 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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Detailed Description

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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.

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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Cohort 1 (200 mg)

Six subjects received 200 mg of lucerastat twice daily for 7 consecutive days in fasting conditions

Group Type EXPERIMENTAL

Lucerastat

Intervention Type DRUG

Capsule for oral administration containing lucerastat

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

Group Type EXPERIMENTAL

Lucerastat

Intervention Type DRUG

Capsule for oral administration containing lucerastat

Cohort 3 (500 mg)

Six subjects received 500 mg of lucerastat twice daily for 7 consecutive days in fasting conditions

Group Type EXPERIMENTAL

Lucerastat

Intervention Type DRUG

Capsule for oral administration containing lucerastat

Cohort 4 (1000 mg)

Six subjects received 1 g of lucerastat for 7 consecutive days in fasting conditions

Group Type EXPERIMENTAL

Lucerastat

Intervention Type DRUG

Capsule for oral administration containing lucerastat

Placebo cohorts 1 to 4

Twelve subjects received matched placebo (3 subjects per cohort, except for Cohort 3 where 4 subjects received placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules matching lucerastat capsules

Interventions

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Lucerastat

Capsule for oral administration containing lucerastat

Intervention Type DRUG

Placebo

Placebo capsules matching lucerastat capsules

Intervention Type DRUG

Other Intervention Names

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OGT-923 ACT-434964 CDP923

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