Trial record 4 of 18 for:    avanir

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Avanir Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02402595
First received: February 26, 2015
Last updated: March 27, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Healthy
Drug: AVP-923
Drug: AVP-786
Drug: Itraconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • Change in plasma concentration of AVP-923 after dosing in combination with itraconazole [ Time Frame: 16 Days ] [ Designated as safety issue: No ]
  • Change in plasma concentration of AVP-786 after dosing in combination with itraconazole [ Time Frame: 16 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events (AEs) for AVP-923 and itraconazole [ Time Frame: 16 Days ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events (AEs) for AVP-786 and itraconazole [ Time Frame: 16 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: March 2015
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02402595

Contacts
Contact: Nadine Knowles 949-268-8972 nknowles@avanir.com

Locations
United States, Kansas
Vince and Associates Clinical Research, Inc. Recruiting
Overland Park, Kansas, United States, 66212
Contact: Kaela Reilly    913-696-1601      
Sponsors and Collaborators
Avanir Pharmaceuticals
Investigators
Principal Investigator: Martin Kankam, MD, PhD, MPH Vince and Associates Clinical Research Inc.
  More Information

No publications provided

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02402595     History of Changes
Other Study ID Numbers: 15-AVP-786-103
Study First Received: February 26, 2015
Last Updated: March 27, 2015
Health Authority: United States: Food and Drug Administration

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:
Hydroxyitraconazole
Itraconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2015