Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 82 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts (DDI)

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: NCT02402595
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.

Condition or disease Intervention/treatment Phase
Healthy Drug: AVP-923 Drug: AVP-786 Drug: Itraconazole Phase 1

Detailed Description:
A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects
Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Sequence 1 - Period 1
AVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
Drug: AVP-923
Drug: Itraconazole
Other Name: Sporanex

Experimental: Sequence 1 - Period 2 (after 3-week washout)
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
Drug: AVP-786
Drug: Itraconazole
Other Name: Sporanex

Experimental: Sequence 2 - Period 1
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
Drug: AVP-786
Drug: Itraconazole
Other Name: Sporanex

Experimental: Sequence 2 - Period 2 (after 3-week washout)
AVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
Drug: AVP-923
Drug: Itraconazole
Other Name: Sporanex




Primary Outcome Measures :
  1. Change in plasma concentration of AVP-923 after dosing in combination with itraconazole [ Time Frame: 16 Days ]
  2. Change in plasma concentration of AVP-786 after dosing in combination with itraconazole [ Time Frame: 16 Days ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) for AVP-923 and itraconazole [ Time Frame: 16 Days ]
  2. Incidence of adverse events (AEs) for AVP-786 and itraconazole [ Time Frame: 16 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Healthy adult males and females, 18 to 55 years of age
  • Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)

Exclusion Criteria:

  • History or presence of significant disease
  • History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes
  • Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose
  • Use of any prescription or the over-the-counter medications within 14 days

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): NCT02402595


Locations
Layout table for location information
United States, Kansas
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Avanir Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Martin Kankam, MD, PhD, MPH Vince and Associates Clinical Research Inc.

Layout table for additonal information
Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02402595     History of Changes
Other Study ID Numbers: 15-AVP-786-103
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

Keywords provided by Avanir Pharmaceuticals:
Drug-drug interaction
Healthy Volunteers
Pharmacokinetics
deuterated dextromethorphan
dextromethorphan
dextromethorphan with quinidine
deuterated dextromethorphan with quinidine
itraconazole

Additional relevant MeSH terms:
Layout table for MeSH terms
Itraconazole
Hydroxyitraconazole
Quinidine
Dextromethorphan
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
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents