Effect of Cimetidine on the Pharmacokinetics of Lucerastat 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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2018-01-29

Brief Summary

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A study in healthy male subjects to investigate whether repeated administrations of cimetidine (a medication which decreases the amount of acid in the stomach) can affect the fate in the body (amount and time of presence in the blood) of lucerastat. Safety of the concomitant administration of the two treatments will also be assessed.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Fixed sequence

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment period A & B

Treatment period A: Subjects receive a single oral dose of 500 mg lucerastat on Day 1 under fasted conditions.

Treatment period B: From Day 3 to Day 9, subjects receive a b.i.d. (every 12 h) oral dose of 800 mg cimetidine under fasted conditions (Treatment period B1; from Day 3 to Day 5). On Day 6, subjects receive a single oral dose of 500 mg lucerastat concomitantly with the morning dose of 800 mg cimetidine under fasted conditions (Treatment period B2; from Day 6 to Day 10).

Group Type EXPERIMENTAL

Lucerastat

Intervention Type DRUG

Single oral dose of 500 mg lucerastat under fasted conditions

Cimetidine

Intervention Type DRUG

Twice daily oral dose of 800 mg cimetidine under fasted conditions

Interventions

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Lucerastat

Single oral dose of 500 mg lucerastat under fasted conditions

Intervention Type DRUG

Cimetidine

Twice daily oral dose of 800 mg cimetidine under fasted conditions

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent in the local language prior to any study-mandated procedure.
* Body mass index from 18.0 to 30.0 kg/m2 (inclusive) at Screening.
* Normal renal function confirmed by creatinine clearance ≥ 80 mL/min using Cockroft-Gault formula at Screening.

Exclusion Criteria

* Known hypersensitivity to cimetidine, lucerastat, or drugs of the same class, or any of their excipients.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed).
* 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