A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lucerastat (CDP923) After Multiple Dosing in Healthy Subjects

Idorsia Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Placebo

Drug: Lucerastat

Study type

Interventional

Funder types

Industry

Identifiers

NCT02944474

CDP923-002

Details and patient eligibility

About

The objectives of this study were to evaluate the safety and tolerability of lucerastat and to determine its pharmacokinetic profile after multiple dosing. Also, the potential effect of food on the pharmacokinetics of lucerastat was explored following a single dose of 500 mg.

Full description

The subjects were to be enrolled sequentially to three dose groups, starting with the lowest dose level. Subjects could participate in only one Group. Progression to an increased dose of lucerastat was permitted only after review of all data from the previous cohort suggested that it was safe to do so.

Enrollment

37 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Signed informed consent form.
Male subjects aged from 18 to 45 years at screening.
Body weight between 50 and 100 kg and body mass index (BMI) between 18.0 and 29.0 kg/m2 at screening.
Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion criteria

History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments.
Serious adverse reaction or hypersensitivity to any drug.
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

37 participants in 5 patient groups, including a placebo group

Cohort 1 (200 mg)

Experimental group

Description:

Six subjects received 200 mg of lucerastat twice daily for 7 consecutive days in fasting conditions

Treatment:

Drug: Lucerastat

Cohort 2 (500 mg)

Experimental group

Description:

Six subjects received 500 mg of lucerastat as a single dose in the morning of Day 1 in fed conditions. After a 5-day washout, they received the same dose twice daily for 7 consecutive days in fasting conditions

Treatment:

Drug: Lucerastat

Cohort 3 (500 mg)

Experimental group

Description:

Six subjects received 500 mg of lucerastat twice daily for 7 consecutive days in fasting conditions

Treatment:

Drug: Lucerastat

Cohort 4 (1000 mg)

Experimental group

Description:

Six subjects received 1 g of lucerastat for 7 consecutive days in fasting conditions