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Trial record 83 of 79776 for:    subjects

Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03380455
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Lucerastat Drug: Cimetidine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Fixed sequence
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-center, Open-label Study to Investigate the Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Male Subjects
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : January 29, 2018
Actual Study Completion Date : January 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cimetidine

Arm Intervention/treatment
Experimental: 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).

Drug: Lucerastat
Single oral dose of 500 mg lucerastat under fasted conditions

Drug: Cimetidine
Twice daily oral dose of 800 mg cimetidine under fasted conditions




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380455


Locations
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Germany
CRS Clinical Research Services Kiel GmbH
Kiel, Germany, 24105
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Marie-Laure Boof, PhD Idorsia Pharmaceuticals Ltd.

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03380455     History of Changes
Other Study ID Numbers: ID-069-105
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors