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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02944487
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Lucerastat Drug: Placebo Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Randomised, Double-blind, Placebo-controlled Ascending Dose Tolerance Study of OGT 923 in Healthy Male Volunteers
Study Start Date : October 2002
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Arm Intervention/treatment
Experimental: Single ascending doses of lucerastat
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
Drug: Lucerastat
Hard gelatin capsule for oral administration containing lucerastat
Other Names:
  • OGT-923
  • ACT-434964

Experimental: B.i.d. Dose Group
Subjects received two doses of lucerastat (2 x 1 g) 12 hours apart on Day 1
Drug: Lucerastat
Hard gelatin capsule for oral administration containing lucerastat
Other Names:
  • OGT-923
  • ACT-434964

Placebo Comparator: Placebo for singe ascending doses
These subjects received matching placebo administered orally in the morning of Day 1
Drug: Placebo
Matching placebo capsules

Placebo Comparator: Placebo for b.i.d.Group
These subjects received matching placebo administered orally in the morning and in the evening of Day 1
Drug: Placebo
Matching placebo capsules




Primary Outcome Measures :
  1. Number of participants with Adverse Events (AEs) [ Time Frame: From baseline up to 7 days post-administration ]
    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.

  2. Maximum plasma concentration (Cmax) of lucerastat after single ascending doses of lucerastat [ Time Frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration ]
    Cmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving a single dose.

  3. Maximum plasma concentration (Cmax) of lucerastat after two daily doses of lucerastat [ Time Frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration ]
    Cmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving lucerastat twice daily.

  4. Time to reach Cmax (tmax) of lucerastat after single ascending doses of lucerastat [ Time Frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration ]
    tmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjectsreceiving a single dose.

  5. Time to reach Cmax (tmax) of lucerastat after two daily doses of lucerastat [ Time Frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration ]
    tmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving lucerastat twice daily.

  6. Area under the plasma concentration-time curves (AUC) of lucerastat after single ascending doses of lucerastat [ Time Frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration ]
    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.

  7. Area under the plasma concentration-time curves (AUC) of lucerastat after two daily doses of lucerastat [ Time Frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration ]
    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

  8. Terminal elimination half-life (t1/2) of lucerastat after single ascending doses of lucerastat [ Time Frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration ]
    t1/2 was calculated from the corresponding plasma concentrations-time curves for subjects receiving a single dose

  9. Terminal elimination half-life (t1/2) of lucerastat after two daily doses of lucerastat [ Time Frame: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration ]
    t1/2 was calculated from the plasma concentrations-time curves for subjects receiving lucerastat twice daily


Secondary Outcome Measures :
  1. Change from baseline in heart rate [ Time Frame: Up to 24 hours post administration ]
  2. Change from baseline in blood pressure [ Time Frame: Up to 24 hours post administration ]
  3. Change from baseline in electrocardiogram (ECG) variables [ Time Frame: Up to 24 hours post administration ]
  4. Change from baseline in laboratory tests [ Time Frame: Up to 24 hours post administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944487


Locations
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United Kingdom
Investigator Site
Tranent, United Kingdom, EH33 2NE
Sponsors and Collaborators
Actelion
Investigators
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OverallOfficial: Nicolas Guérard Actelion
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02944487    
Other Study ID Numbers: OGT923-001
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Actelion:
safety
pharmacokinetics