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Trial record 10 of 180 for:    ERYTHROMYCIN

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

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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. )

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Padsevonil (UCB0942) Drug: Erythromycin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Fixed-sequence Study in Healthy Study Participants to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil
Actual Study Start Date : March 27, 2018
Actual Primary Completion Date : August 2, 2018
Actual Study Completion Date : August 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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) ]
  4. 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) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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 ]
  9. 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 ]
  10. 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) ]
  11. 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 ]
  12. 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 ]
  13. 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) ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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 ]
  18. 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 ]
  19. 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 ]
  20. 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 ) ]
  21. 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 ) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03480243


Locations
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United Kingdom
Up0057 001
London, United Kingdom
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03480243     History of Changes
Other Study ID Numbers: UP0057
2017-004694-13 ( EudraCT Number )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Padsevonil
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action