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A Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 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: NCT03209648
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Tracking Information
First Submitted Date  ICMJE July 4, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date October 18, 2017
Actual Study Start Date  ICMJE June 14, 2017
Actual Primary Completion Date August 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
  • Maximum Observed Plasma Concentration (Cmax) of Debio 1452 [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
  • Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC0-∞) of Debio 1452 [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
  • Area Under the Plasma Concentration-time Curve from Time Zero to Time (t) (AUC0-t) of Debio 1452 [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
  • Area Under the Plasma Concentration-time Curve from Time Zero to 12 Hours Postdose (AUC0-12) of Debio 1452, Debio 1450, Debio 1452-M1, and desmethyl Debio 1452 [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
  • Time to Reach Maximum Concentration (Tmax) of Debio 1452, Debio 1450, Debio 1452-M1, desmethyl Debio 1452 and Itraconazole [ Time Frame: Debio 1450 and its metabolites: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose. Itraconazole: Days 1, 3, and 6: predose, Days 4 and 5: predose, and 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose ]
  • Apparent Plasma Terminal Elimination Half-life (t1/2) of Debio 1452, Debio 1450, Debio 1452-M1, desmethyl Debio 1452 and Itraconazole [ Time Frame: Debio 1450 and its metabolites: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose. Itraconazole: Days 1, 3, and 6: predose, Days 4 and 5: predose, and 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose ]
  • Mean Residence Time (MRT) of Debio 1452, Debio 1450, Debio 1452-M1, and desmethyl Debio 1452 [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
    the mean residence time is the average time the drug stays at the site of action.
  • Apparent Total Body Clearance of a Drug from the Plasma (CL/F) of Debio 1452 [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
  • Apparent Volume of Distribution During the Terminal (lamdaz) Phase (Vz/F) of Debio 1452 [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
    Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
  • Maximum Observed Plasma Concentration (Cmax) of Debio 1450, Debio 1452-M1, desmethyl Debio 1452 and Itraconazole [ Time Frame: Debio 1450 and its metabolites: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose. Itraconazole: Days 1, 3, and 6: predose, Days 4 and 5: predose, and 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose ]
  • Area Under the Plasma Concentration-time Curve from Time Zero to Time (t) (AUC0-t) of Debio 1450, Debio 1452-M1 and desmethyl Debio 1452 [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
  • Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC0-infinity) of Debio 1450, Debio 1452-M1 and desmethyl Debio 1452 [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
  • Metabolite:Parent Cmax Ratio (for Debio 1452-M1 and desmethyl Debio 1452 only; Debio 1452 as Parent; Based on Molar Data) [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
  • Metabolite:Parent AUC ratio (for Debio 1452-M1 and desmethyl Debio 1452 only; Debio 1452 as Parent; Based on Molar Data) [ Time Frame: Days 1 and 5: predose and 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 30, 36, 48, and 60 hours postdose ]
  • Area Under the Plasma Concentration-time Curve During a Dosing Interval at Steady State (AUC0-τ) of Itraconazole [ Time Frame: Days 1, 3, and 6: predose Days 4 and 5: predose, and 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose ]
  • Measured Concentration at the end of a Dosing Interval at Steady State (Ctrough) of Itraconazole [ Time Frame: Days 1, 3, and 6: predose Days 4 and 5: predose, and 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose ]
  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 7 ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
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 Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects
Official Title  ICMJE A Phase 1, Open-Label, Fixed Sequence Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects
Brief Summary Debio 1450 is metabolised mainly by CYP3A4, therefore inhibitors of CYP3A4 have the potential to raise Debio 1450 plasma concentrations. Hence, it is important to determine the effect of CYP3A4 inhibition by itraconazole on the Pharmacokinetics of Debio 1450.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: Debio 1450
    Debio 1450, 40 mg capsule.
  • Drug: Itraconazole
    Itraconazole, 20 mL of 10 mg/mL solution.
Study Arms  ICMJE Experimental: Debio 1450
In Treatment Period 1, participants will receive single oral dose of Debio 1450 40 mg on Day 1. In Treatment Period 2, participants will receive itraconazole 200 mg, twice daily (BID) orally, on Day 1, followed by itraconazole 200 mg once daily (QD), on Days 2 to 4, and then single oral dose of Debio 1450 40 mg and itraconazole 200 mg on Day 5, followed by a single oral dose of itraconazole 200 mg on Days 6 and 7.
Interventions:
  • Drug: Debio 1450
  • Drug: Itraconazole
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: July 4, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date August 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets protocol-specified criteria for qualification and contraception.
  • Is willing and able to comply with restrictions related to food, drink and medications.
  • Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures.

Exclusion Criteria:

  • Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters.
  • Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

    • the safety or well-being of the participant or study staff.
    • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); the analysis of results.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 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 NCT03209648
Other Study ID Numbers  ICMJE Debio 1450-111
2017-001352-60 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
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 Debiopharm International SA
Study Sponsor  ICMJE Debiopharm International SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Debiopharm International SA
Verification Date October 2017

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