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Completed

NCT Number: NCT03380455

Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Subjects

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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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lucerastat

Drug

Single oral dose of 500 mg lucerastat under fasted conditions

Cimetidine

Drug

Twice daily oral dose of 800 mg cimetidine under fasted conditions

Primary outcomes

  1. Cmax of lucerastat

    Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days

    Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine

  2. Tmax of lucerastat

    Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days

    Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine

  3. AUC(0-t) of lucerastat

    Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days

    Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine

  4. AUC(0-inf) of lucerastat

    Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days

    Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine

  5. AUC(0-48) of lucerastat

    Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days

    Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine

  6. T1/2 of lucerastat

    Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days

    Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine

Secondary outcomes

  1. Number of treatment-emergent AEs

    Time frame: From Day 1 to End-of-Study (for up to 13 days)

  2. Number of treatment-emergent SAEs

    Time frame: From Screening to safety follow-up, i.e., 32 days after End-of-Study (for up to 63 days)

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

A Single-center, Open-label Study to Investigate the Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Male Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2017
Registry last updated
Jun 2, 2022

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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