Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03380455
Other study ID # ID-069-105
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT05483998 - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants Phase 1
Recruiting NCT02235012 - Cognitive Biases Under Ketamine N/A
Recruiting NCT02417714 - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Completed NCT05088343 - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects Phase 1
Completed NCT04418973 - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject. N/A
Not yet recruiting NCT06248801 - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets Phase 1
Terminated NCT04068259 - Single Ascending Dose Study of PBI-4547 in Healthy Subjects Phase 1
Completed NCT03279302 - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects Phase 1
Not yet recruiting NCT06233162 - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets Phase 1
Recruiting NCT04159844 - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects N/A
Completed NCT06137911 - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults. Phase 1
Completed NCT04849286 - Measurement of HTL0016878 in Cerebrospinal Fluid Phase 1
Not yet recruiting NCT06233227 - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule Phase 1
Completed NCT04096157 - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants Phase 1
Completed NCT01200368 - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants Phase 3
Recruiting NCT05805033 - Peri-Implant Soft Tissue Integration in Humans: Influence of Material N/A
Completed NCT04027803 - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® Phase 1
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT02903095 - Single Ascending Dose Study of TD-1439 in Healthy Subjects Phase 1
Active, not recruiting NCT02341508 - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers Phase 1