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Trial record 86 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

Evaluation of Metabolic Markers for the Prediction of DDI of Various CYP3A Substrates and Inhibitors

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ClinicalTrials.gov Identifier: NCT02975037
Recruitment Status : Unknown
Verified November 2016 by Joo-Youn Cho, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Joo-Youn Cho, Seoul National University Hospital

Brief Summary:
Evaluation and validation of metabolic markers for the prediction of drug-drug interaction of various CYP3A4 substrates (sildenafil) and inhibitors (erythromycin/itraconazole) in healthy male subjects

Condition or disease Intervention/treatment Phase
Healthy Drug: Sildenafil Drug: Erythromycin Drug: Itraconazole Phase 4

Detailed Description:

Subjects suitable for this study will be admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they will be overnight-fasted from 9P of Day -1. Urine collection is scheduled from 12 hours before sildenafil administration to 12 hours after administration. Subjects will be administered sildenafil (oral) around at 9A of Day 1. Subjects will perform scheduled procedures including clinical laboratory tests, electrocardiograms and blood samplings for pharmacokinetic, pharmacometabolomic and mRNA assessment.

Subjects will be administered either erythromycin or itraconazole (oral) around at 9A on Day 3 and 9A/9P on Day 4. Urine collection is scheduled from 0 hour to 12 hours after Day 3 erythromycin or itraconazole administration. Subjects will perform scheduled procedures including clinical laboratory tests, electrocardiograms and blood samplings for pharmacokinetic, pharmacometabolomic and mRNA assessment.

On Day 5, sildenafil will be administered with erythromycin or itraconazole around at 9A. Urine collection is scheduled from 12 hours before Day 5 drug administration to 12 hours after administration. Subjects will perform scheduled procedures. After subjects perform scheduled procedure, the study will be discharged (around 9A of Day 6).

Study participation was terminated on post-study visit (Day 12-14).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation and Validation of Metabolic Markers for the Prediction of Drug-drug Interaction of Various CYP3A4 Substrates and Inhibitors in Healthy Male Subjects
Study Start Date : December 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017


Arm Intervention/treatment
Experimental: sildenafil+erythromycin
Sildenafil 25 mg PO (single dose); Erythromycin 250 mg PO (3 doses); Sildenafil 25 mg PO + Erythromycin 250 mg PO (single dose)
Drug: Sildenafil
sildenafil 25 mg PO
Other Name: VIAGRA TAB, Pfizer Pharmaceuticals Korea Limited, Korea

Drug: Erythromycin
erythromycin 250 mg PO
Other Name: ERYTHIN CAP 250MG, Wooridul Pharmaceutical Co.,Ltd., Korea

Experimental: sildenafil+itraconazole
Sildenafil 25 mg PO (single dose); Itraconazole 100 mg PO (3 doses); Sildenafil 25 mg PO + Itraconazole 100 mg PO (single dose)
Drug: Sildenafil
sildenafil 25 mg PO
Other Name: VIAGRA TAB, Pfizer Pharmaceuticals Korea Limited, Korea

Drug: Itraconazole
itraconazole 100 mg PO
Other Name: ITRA TAB, Hanmi Pharm.Co.,Ltd., Korea




Primary Outcome Measures :
  1. Quantification of endogenous metabolites (plasma) [ Time Frame: day 1 0h, day 3 0h, day 5 0h ]
    Metabolomic profiles to predict CYP3A activity

  2. Quantification of endogenous metabolites (urine) [ Time Frame: day -1 12h~day 1 0h, day 1 0h~12h, day 3 0h~12h, day 4 12h~ day 5 0h, day 5 0h~12h ]
    Metabolomic profiles to predict CYP3A activity


Secondary Outcome Measures :
  1. Peak plasma concentration (Cmax) [ Time Frame: day 1 0h (pre-dose), 10, 20, 30, 45 min, 1, 2, 3, 4, 6, 8, 12, 24h; day 3 0h (pre-dose), 10, 20, 30, 45 min, 1, 2, 3, 4, 6, 8, 12, 24h; day 5 0h (pre-dose), 10, 20, 30, 45 min, 1, 2, 3, 4, 6, 8, 12, 24h ]
    Pharmacokinetics of CYP3A substrate and inhibitors

  2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: day 1 0h (pre-dose), 10, 20, 30, 45 min, 1, 2, 3, 4, 6, 8, 12, 24h; day 3 0h (pre-dose), 10, 20, 30, 45 min, 1, 2, 3, 4, 6, 8, 12, 24h; day 5 0h (pre-dose), 10, 20, 30, 45 min, 1, 2, 3, 4, 6, 8, 12, 24h ]
    Pharmacokinetics of CYP3A substrate and inhibitors


Other Outcome Measures:
  1. Quantification of mRNA (whole blood) [ Time Frame: day -1 12h, day 1 0, 12h, day 3 0, 12h, day 4 12h, day 5 0, 12h ]
    Quantification of mRNA for CYP3A activity



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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: Between 19 to 50 years of age, inclusive
  • Weight: within 17-28 of Body Mass Index (BMI)
  • Subject who are reliable and willing to make themselves available during the study period.
  • Subject who are willing to follow the study protocol, and give their written informed consent voluntarily.

Exclusion Criteria:

  • History of hypersensitive reaction to medication (midazolam, itraconazole, rifampicin)
  • History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
  • History or evidence of drug abuse
  • Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
  • Participation in clinical trials of any drug within 3 months prior to the participation of the study
  • Judged to be inappropriate for the study by the investigator

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Responsible Party: Joo-Youn Cho, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02975037     History of Changes
Other Study ID Numbers: CYP3A_DDI
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Sildenafil Citrate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors