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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

Tracking Information
First Submitted Date  ICMJE October 24, 2016
First Posted Date  ICMJE October 26, 2016
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE October 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • Change from baseline in heart rate [ Time Frame: Up to 24 hours post administration ]
  • Change from baseline in blood pressure [ Time Frame: Up to 24 hours post administration ]
  • Change from baseline in electrocardiogram (ECG) variables [ Time Frame: Up to 24 hours post administration ]
  • Change from baseline in laboratory tests [ Time Frame: Up to 24 hours post administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Pharmacokinetics of Lucerastat (OGT 923) in Healthy Subjects
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled Ascending Dose Tolerance Study of OGT 923 in Healthy Male Volunteers
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.
Detailed Description The subjects were enrolled sequentially to five dose groups, starting with the lowest dose level. Subjects could participate in only one Group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: Lucerastat
    Hard gelatin capsule for oral administration containing lucerastat
    Other Names:
    • OGT-923
    • ACT-434964
  • Drug: Placebo
    Matching placebo capsules
Study Arms  ICMJE
  • 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
    Intervention: Drug: Lucerastat
  • Experimental: B.i.d. Dose Group
    Subjects received two doses of lucerastat (2 x 1 g) 12 hours apart on Day 1
    Intervention: Drug: Lucerastat
  • Placebo Comparator: Placebo for singe ascending doses
    These subjects received matching placebo administered orally in the morning of Day 1
    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: Placebo
Publications * Guérard N, Morand O, Dingemanse J. Lucerastat, an iminosugar with potential as substrate reduction therapy for glycolipid storage disorders: safety, tolerability, and pharmacokinetics in healthy subjects. Orphanet J Rare Dis. 2017 Jan 14;12(1):9. doi: 10.1186/s13023-017-0565-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
39
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02944487
Other Study ID Numbers  ICMJE OGT923-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Nicolas Guérard Actelion
PRS Account Actelion
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP