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Trial record 10 of 185 for:    ERYTHROMYCIN

Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil

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: NCT03480243
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE March 21, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE March 27, 2018
Actual Primary Completion Date August 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
  • Maximum observed plasma concentration (Cmax) of Padsevonil for single dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 12 h post first dose of Padsevonil for each Treatment Period ]
  • Area under the plasma concentration-time curve from time zero to 12 hours (AUC(0-12)) of Padsevonil for single dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 12 h post first dose of Padsevonil for each Treatment Period ]
  • Maximum observed steady-state plasma concentration (Cmax, ss) of Padsevonil for multiple dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 72 h post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 h post last dose of PSL (Treatment Period 3) ]
  • Area under the plasma concentration-time curve over a dosing interval (12 hrs) (AUCtau) of Padsevonil for multiple dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 72 h post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 h post last dose of PSL (Treatment Period 3) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03480243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
  • Time of maximum plasma concentration (tmax) of Padsevonil and metabolites (UCB1431322-000 and UCB14474499-000) for single dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 12 h post first dose of Padsevonil for each Treatment Period ]
  • Minimum observed plasma concentration (Cmin) of Padsevonil and metabolites (UCB1431322-000 and UCB14474499-000) for single dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 12 h post first dose of Padsevonil for each Treatment Period ]
  • Time of maximum plasma concentration (tmax) of Padsevonil and metabolites (UCB1431322-000 and UCB14474499-000) for multiple dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 72 h post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 h post last dose of PSL (Treatment Period 3) ]
  • Apparent terminal elimination half-life at steady-state (t1/2,ss) of Padsevonil and metabolites (UCB1431322-000 and UCB14474499-000) for multiple dose in plasma [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 72 h post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 h post last dose of PSL (Treatment Period 3) ]
  • Predose observed plasma concentration (Ctrough) of Padsevonil and metabolites (UCB1431322-000 and UCB14474499-000) for multiple dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 72 h post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 h post last dose of PSL (Treatment Period 3) ]
  • Apparent total clearance at steady-state (CL/Fss) of Padsevonil and metabolites (UCB1431322-000 and UCB14474499-000) for multiple dose in plasma [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 72 h post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 h post last dose of PSL (Treatment Period 3) ]
  • Terminal rate constant (lambdaz) of Padsevonil and metabolites (UCB1431322-000 and UCB14474499-000) for multiple dose in plasma [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 72 h post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 h post last dose of PSL (Treatment Period 3) ]
  • Maximum observed plasma concentration (Cmax) of metabolites (UCB1431322-000 and UCB14474499-000) for single dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 12 h post first dose of Padsevonil for each Treatment Period ]
  • Area under the plasma concentration-time curve from time zero to 12 hrs (AUC(0-12)) of metabolites (UCB1431322-000 and UCB14474499-000) for single dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 12 h post first dose of Padsevonil for each Treatment Period ]
  • Area under the plasma concentration-time curve over a dosing interval (12 hrs) (AUCtau) of metabolites (UCB1431322-000 and UCB14474499-000) for multiple dose [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 72 h post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 h post last dose of PSL (Treatment Period 3) ]
  • Metabolite-to-parent ratio for Cmax of metabolites (UCB1431322-000 and UCB14474499-000) in plasma [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 12 h post dose of Padsevonil for each Treatment Period ]
  • Metabolite-to-parent ratio for AUC(0-12) of metabolites (UCB1431322-000 and UCB14474499-000) in plasma [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 12 h post first dose of Padsevonil for each Treatment Period ]
  • Metabolite-to-parent ratio for AUCtau of metabolites (UCB1431322-000 and UCB14474499-000) in plasma [ Time Frame: Blood samples will be taken at specific time points from pre-dose to 72 h post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 h post last dose of PSL (Treatment Period 3) ]
  • Renal clearance (CLr) of Padsevonil and metabolites (UCB1431322-000, UCB14474499-000 and UCB1478802-000) for single dose in urine [ Time Frame: Urine samples will be taken 0 h to 12 h post first dose of Padsevonil during each Treatment Period ]
  • Renal clearance (CLr) of Padsevonil and metabolites (UCB1431322-000, UCB14474499-000 and UCB1478802-000) for multiple dose in urine [ Time Frame: Urine samples will be taken 0 h to 12 h, 12 h to 24 h, and 24 h to 48 h post last PSL dose during Treatment Period 1 and 2; 0 h to 12 h, 12 h to 24 h, 24 h to 48 h, 48 h to 72 h, and 72 h to 96 h post last dose of PSL during Treatment Period 3 ]
  • Cumulative amount (Ae) of Padsevonil and metabolites (UCB1431322-000, UCB14474499-000 and UCB1478802-000) excreted into the urine for single dose [ Time Frame: Urine samples will be taken 0 h to 12 h post first dose of Padsevonil during each Treatment Period ]
  • Cumulative amount (Ae) of Padsevonil and metabolites (UCB1431322-000, UCB14474499-000 and UCB1478802-000) excreted into the urine for multiple dose [ Time Frame: Urine samples will be taken 0 h to 12 h, 12 h to 24 h, and 24 h to 48 h post last PSL dose during Treatment Period 1 and 2; 0 h to 12 h, 12 h to 24 h, 24 h to 48 h, 48 h to 72 h, and 72 h to 96 h post last dose of PSL during Treatment Period 3 ]
  • Fraction (fe) of Padsevonil and metabolites (UCB1431322-000, UCB14474499-000 and UCB1478802-000) excreted into the urine for single dose [ Time Frame: Urine samples will be taken 0 h to 12 h post first dose of Padsevonil during each Treatment Period ]
  • Fraction (fe) of Padsevonil and metabolites (UCB1431322-000, UCB14474499-000 and UCB1478802-000) excreted into the urine for multiple dose [ Time Frame: Urine samples will be taken 0 h to 12 h, 12 h to 24 h, and 24 h to 48 h post last PSL dose during Treatment Period 1 and 2; 0 h to 12 h, 12 h to 24 h, 24 h to 48 h, 48 h to 72 h, and 72 h to 96 h post last dose of PSL during Treatment Period 3 ]
  • Incidence of Treatment-Emergent Serious Adverse Events (SAEs) during the study [ Time Frame: From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to 48 days ) ]
  • Incidence of Treatment-Emergent non-serious Adverse Events (AEs) during the study [ Time Frame: From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to 48 days ) ]
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 Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil
Official Title  ICMJE An Open-label, Fixed-sequence Study in Healthy Study Participants to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil
Brief Summary The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy study participants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • Drug: Padsevonil (UCB0942)
    • Pharmaceutical Form: film-coated tablet
    • Route of Administration: Oral use
  • Drug: Erythromycin
    • Pharmaceutical Form: film-coated tablet
    • Route of Administration: Oral use
Study Arms  ICMJE Experimental: Padsevonil and Erythromycin

Treatment Period 1 (Day 1 to Day 11):

  • Padsevonil 100 mg twice daily (bid) on Day 1 to Day 4
  • Padsevonil 100 mg single dose on Day 5
  • 1 week of wash-out (from evening of Day 5 to Day 11)

Treatment Period 2 (Day 12 to 22):

  • Padsevonil 100 mg twice daily (bid) on Day 12 to Day 15
  • Padsevonil 100 mg single dose on Day 16
  • 1 week of wash-out (from evening of Day 16 to Day 22)

Treatment Period 3 (Day 23 to Day 38):

  • Erythromycin 500 mg twice daily (bid) on Day 23 to Day 25
  • Padsevonil 100 mg bid and erythromycin 500 mg bid on Day 26 to Day 32
  • Padsevonil 100 mg single dose on Day 33
  • Erythromycin 500 mg twice daily (bid) on Day 33 to Day 36
  • Erythromycin 500 mg single dose on Day 37
Interventions:
  • Drug: Padsevonil (UCB0942)
  • Drug: Erythromycin
Publications * Not Provided

*   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: March 21, 2018)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2, 2018
Actual Primary Completion Date August 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Study participant is male or female and between 18 and 55 years of age (inclusive)
  • Study participant is of a body weight of at least 50 kg for males and 45 kg for females, as determined by a body mass index (BMI) between 18 and 30 kg/m^2
  • Female study participants use an efficient form of contraception for the duration of the study (unless menopausal). Hormonal contraception may be susceptible to an interaction with the Investigational Medicinal Product (IMP), which may reduce the efficacy of the contraception method. The potential for reduced efficacy of any hormonal contraception methods requires that a barrier method (preferably male condom) also be used
  • Study participant has clinical laboratory test results within the local reference ranges or values are considered as not clinically relevant by the investigator and approved by the UCB Study Physician
  • Study participant has Blood Pressure (BP) and pulse rate within normal range in supine position after 10 minutes of rest
  • Male study participant agrees that, during the study period, when having sexual intercourse with a woman of childbearing potential, he will use an efficient barrier contraceptive (condom plus spermicide) AND that the respective partner will use an additional efficient contraceptive method

Exclusion Criteria:

  • Study participant has previously received Investigational Medicinal Product (IMP) in this study
  • Study participant has participated in another study of an IMP (or a medical device) within the previous 3 months before Screening (or within 5 half-lives for the IMP, whichever is longer) or is currently participating in another study of an IMP (or a medical device)
  • Study participant has a history of drug or alcohol dependency within the previous 6 months or tests positive for alcohol (breath test) and/or drugs of abuse (urine test) at the Screening Visit or at any time during confinement
  • Study participant has made a blood or plasma donation or has had a comparable blood loss (>400 mL) within the last 3 months prior to the Screening Visit
  • Study participant smokes more than 5 cigarettes per day (or equivalent) or has done so within 6 months prior to the Screening Visit
  • Study participant is taking any concomitant medication currently or within 2 weeks prior to the first day of dosing with the exception of paracetamol (acetaminophen)
  • Study participant has any clinically relevant Electrocardiogram (ECG) finding at the Screening Visit or confinement
  • Study participant has a history within the last 5 years or present condition of malignancy, with the exception of basal cell carcinoma
  • Female study participant tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 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 NCT03480243
Other Study ID Numbers  ICMJE UP0057
2017-004694-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares 001 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date July 2019

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