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Trial record 26 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03755778
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Pharmaceutical Research Associates
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Brief Summary:
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects

Condition or disease Intervention/treatment Phase
RSV Infection Drug: EDP-938 Drug: Itraconazole Drug: Rifampin Drug: Quinidine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 3-Part Single Group study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: EDP-938 and itraconazole interaction (Part 1) Drug: EDP-938
Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 1)

Drug: Itraconazole
Subjects will receive itraconazole once daily from Day 5 to Day 18

Experimental: EDP-938 and rifampin interaction (Part 2) Drug: EDP-938
Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 2)

Drug: Rifampin
Subjects will receive rifampin once daily from Day 5 to Day 16

Experimental: EDP-938 and quinidine interaction (Part 3) Drug: EDP-938
Subjects will receive EDP-938 once daily on Day 1 and 8 (Part 3)

Drug: Quinidine
Subjects will receive quinidine once daily from Day 5 to Day 12




Primary Outcome Measures :
  1. Cmax of EDP-938 with and without coadministration with itraconazole [ Time Frame: Up to 19 days ]
  2. AUC of EDP-938 with and without coadministration with itraconazole [ Time Frame: Up to 19 days ]
  3. Cmax of EDP-938 with and without coadministration with rifampin [ Time Frame: Up to 17 days ]
  4. AUC of EDP-938 with and without coadministration with rifampin [ Time Frame: Up to 17 days ]
  5. Cmax of EDP-938 with and without coadministration with quinidine [ Time Frame: Up to 13 days ]
  6. AUC of EDP-938 with and without coadministration with quinidine [ Time Frame: Up to 13 days ]

Secondary Outcome Measures :
  1. Safety measured by adverse events [ Time Frame: Up to 25 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:

  • An informed consent document signed and dated by the subject.
  • Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
  • Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
  • Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.

Exclusion Criteria:

  • Clinically relevant evidence or history of illness or disease.
  • For Part 3 subjects, the following cardiovascular abnormalities:

    • QRS duration >110 ms
    • Incomplete right bundle branch block or any complete bundle branch block
    • Heart rate <40 or >90 beats per minute (per vital sign capture while rested)
    • History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
    • Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
    • PR interval >220 ms or any 2nd or 3rd degree AV block
    • Ventricular pre-excitation
  • Pregnant or nursing females.
  • History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
  • A positive urine drug screen at Screening or Day -1.
  • Current tobacco smokers or use of tobacco within 3 months prior to Screening.
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
  • History of regular alcohol consumption.
  • Participation in a clinical trial within 30 days prior to the first dose of study drug.

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): NCT03755778


Contacts
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Contact: Enanta Pharmaceuticals 617 607 0705 nadda@enanta.com

Locations
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United States, Kansas
Pharmaceutical Research Associates, Inc., Recruiting
Lenexa, Kansas, United States, 66219
Contact: Shannon Kirk    913-410-2258    KirkShannon@prahs.com   
Principal Investigator: Daniel Dickerson, MD         
Sponsors and Collaborators
Enanta Pharmaceuticals
Pharmaceutical Research Associates
Investigators
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Study Director: Enanta Pharmaceuticals Enanta Pharmaceuticals, Inc

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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03755778     History of Changes
Other Study ID Numbers: EDP 938-003
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Enanta Pharmaceuticals:
drug-drug interaction

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rifampin
Quinidine
Quinidine gluconate
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers