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

Healthy Subjects Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled Ascending Dose Tolerance Study of OGT 923 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944487
• Other study ID #: OGT923-001
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2016
• Last updated: October 24, 2016
• Start date: October 2002
• Est. completion date: December 2002

Study information

• Verified date: October 2016
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Lucerastat
Hard gelatin capsule for oral administration containing lucerastat
• Placebo
Matching placebo capsules

Locations

Country	Name	City	State
United Kingdom	Investigator Site	Tranent

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events (AEs)	An AE was defined as any untoward medical occurrence in a clinical investigation subject, which did not necessarily have a causal relationship with the treatment.	From baseline up to 7 days post-administration	Yes
Primary	Maximum plasma concentration (Cmax) of lucerastat after single ascending doses of lucerastat	Cmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving a single dose.	PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration	No
Primary	Maximum plasma concentration (Cmax) of lucerastat after two daily doses of lucerastat	Cmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving lucerastat twice daily.	PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration	No
Primary	Time to reach Cmax (tmax) of lucerastat after single ascending doses of lucerastat	tmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjectsreceiving a single dose.	PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration	No
Primary	Time to reach Cmax (tmax) of lucerastat after two daily doses of lucerastat	tmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving lucerastat twice daily.	PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration	No
Primary	Area under the plasma concentration-time curves (AUC) of lucerastat after single ascending doses of lucerastat	AUC was calculated from time zero to time t (last PK blood sample in which drug was detected) and extrapolated to infinity for subjects receiving a single dose.	PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration	No
Primary	Area under the plasma concentration-time curves (AUC) of lucerastat after two daily doses of lucerastat	AUC was calculated from time zero to time t (last PK blood sample in which drug was detected) and extrapolated to infinity for subjects receiving lucerastat twice daily	PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration	No
Primary	Terminal elimination half-life (t1/2) of lucerastat after single ascending doses of lucerastat	t1/2 was calculated from the corresponding plasma concentrations-time curves for subjects receiving a single dose	PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration	No
Primary	Terminal elimination half-life (t1/2) of lucerastat after two daily doses of lucerastat	t1/2 was calculated from the plasma concentrations-time curves for subjects receiving lucerastat twice daily	PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration	No
Secondary	Change from baseline in heart rate		Up to 24 hours post administration	Yes
Secondary	Change from baseline in blood pressure		Up to 24 hours post administration	Yes
Secondary	Change from baseline in electrocardiogram (ECG) variables		Up to 24 hours post administration	Yes
Secondary	Change from baseline in laboratory tests		Up to 24 hours post administration	Yes