A Study to Assess the Safety and Pharmacokinetics of Lucerastat (OGT 923) 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

NCT02944487

OGT923-001

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 as single oral doses at different strengths.

Full description

The subjects were enrolled sequentially to five dose groups, starting with the lowest dose level. Subjects could participate in only one Group.

Enrollment: 39 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

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39 participants in 4 patient groups, including a placebo group

Single ascending doses of lucerastat

Experimental group

Description:

Subjects were enrolled sequentially in 4 groups and received a single oral dose of lucerastat from 100 mg to 1000 mg in the morning of Day 1

Treatment:

Drug: Lucerastat

B.i.d. Dose Group

Experimental group

Description:

Subjects received two doses of lucerastat (2 x 1 g) 12 hours apart on Day 1

Treatment:

Drug: Lucerastat

Placebo for singe ascending doses

Placebo Comparator group

Description:

These subjects received matching placebo administered orally in the morning of Day 1

Treatment:

Drug: Placebo

Placebo for b.i.d.Group

Placebo Comparator group

Description:

These subjects received matching placebo administered orally in the morning and in the evening of Day 1

Treatment:

Drug: Placebo