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Trial record 1 of 1 for:    NCT02944474
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A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lucerastat (CDP923) After Multiple Dosing in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02944474
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 after multiple dosing. Also, the potential effect of food on the pharmacokinetics of lucerastat was explored following a single dose of 500 mg.

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Randomised Double-blind, Placebo-controlled, Ascending Multiple Dose Phase 1 Study of CDP923 in Healthy Volunteers to Assess Safety, Tolerability, Pharmacokinetics and Food Effect
Study Start Date : December 2003
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Arm Intervention/treatment
Experimental: Cohort 1 (200 mg)
Six subjects received 200 mg of lucerastat twice daily for 7 consecutive days in fasting conditions
Drug: Lucerastat
Capsule for oral administration containing lucerastat
Other Names:
  • OGT-923
  • ACT-434964
  • CDP923

Experimental: Cohort 2 (500 mg)
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
Drug: Lucerastat
Capsule for oral administration containing lucerastat
Other Names:
  • OGT-923
  • ACT-434964
  • CDP923

Experimental: Cohort 3 (500 mg)
Six subjects received 500 mg of lucerastat twice daily for 7 consecutive days in fasting conditions
Drug: Lucerastat
Capsule for oral administration containing lucerastat
Other Names:
  • OGT-923
  • ACT-434964
  • CDP923

Experimental: Cohort 4 (1000 mg)
Six subjects received 1 g of lucerastat for 7 consecutive days in fasting conditions
Drug: Lucerastat
Capsule for oral administration containing lucerastat
Other Names:
  • OGT-923
  • ACT-434964
  • CDP923

Placebo Comparator: Placebo cohorts 1 to 4
Twelve subjects received matched placebo (3 subjects per cohort, except for Cohort 3 where 4 subjects received placebo)
Drug: Placebo
Placebo capsules matching lucerastat capsules




Primary Outcome Measures :
  1. Dose proportionality in lucerastat pharmacokinetics assessed by maximum plasma concentration (Cmax) [ Time Frame: PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose ]
    Cmax was used to assess dose proportionality across all dose groups

  2. Dose proportionality in lucerastat pharmacokinetics assessed by area under the concentration-time curve (AUC) [ Time Frame: PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7 ]
    AUC from time zero to infinity [AUC(0-inf)] was used to assess dose proportionality across all dose groups

  3. Terminal elimination half-life (t1/2) [ Time Frame: PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7 ]
    t1/2 was calculated from the plasma concentrations-time curves of lucerastat after multiple doses

  4. Food effect on lucerastat pharmacokinetics assessed by Cmax [ Time Frame: PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose ]
    Potential food effect on pharmacokinetic parameters of lucerastat was tested by comparing Cmax in fed vs fasted state in the 500 mg cohort (cohort 2)

  5. Food effect on lucerastat pharmacokinetics assessed by AUC [ Time Frame: PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose ]
    Potential food effect on pharmacokinetic parameters of lucerastat was tested by comparing AUC in fed versus fasted state in the 500 mg cohort (cohort 2)

  6. Number of participants with adverse events (AEs) [ Time Frame: From baseline up to Day 14 (end of study) ]
    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

  7. Change from baseline in haematology after multiple doses of lucerastat [ Time Frame: Up to Day 9 ]
  8. Change from baseline in clinical chemistry after mutliple doses of lucerastat [ Time Frame: Up to Day 9 ]
  9. Change from baseline in heart rate after mutliple doses of lucerastat [ Time Frame: Up to Day 9 ]

Secondary Outcome Measures :
  1. Change from baseline in haematology after a single dose of lucerastat [ Time Frame: At 24 hours post dose ]
  2. Change from baseline in clinical chemistry after a single dose of lucerastat [ Time Frame: At 24 hours post dose ]
  3. Change from baseline in heart rate after a single dose of lucerastat [ Time Frame: At 24 hours post dose ]
  4. Change from baseline in blood pressure after a single dose of lucerastat [ Time Frame: Up to 24 hours post dose ]
  5. Change from baseline in electrocardiogram (ECG) variables after a single dose of lucerastat [ Time Frame: Up to 24 hours post dose ]
  6. Stool frequency after multiple doses of lucerastat [ Time Frame: Every day up to Day 9 ]
  7. Change from baseline in body weight after multiple doses of lucerastat [ Time Frame: At Day 9 ]


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): NCT02944474


Locations
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United Kingdom
Investigator Site
Edinburgh, United Kingdom, EH14 4AP
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: NCT02944474    
Other Study ID Numbers: CDP923-002
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:
Pharmacokinetics
Safety