Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380455
• Other study ID #: ID-069-105
• Status: Completed
• Phase: Phase 1
• Start date: January 9, 2018
• Est. completion date: January 29, 2018

Study information

• Verified date: June 2022
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 29, 2018
• Est. primary completion date: January 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Lucerastat
Single oral dose of 500 mg lucerastat under fasted conditions
• Cimetidine
Twice daily oral dose of 800 mg cimetidine under fasted conditions

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of lucerastat	Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine	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
Primary	Tmax of lucerastat	Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine	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
Primary	AUC(0-t) of lucerastat	Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine	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
Primary	AUC(0-inf) of lucerastat	Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine	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
Primary	AUC(0-48) of lucerastat	Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine	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
Primary	T1/2 of lucerastat	Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine	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
Secondary	Number of treatment-emergent AEs		From Day 1 to End-of-Study (for up to 13 days)
Secondary	Number of treatment-emergent SAEs		From Screening to safety follow-up, i.e., 32 days after End-of-Study (for up to 63 days)