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A Phase 1 Study Comparing AVP-786 With AVP-923

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ClinicalTrials.gov Identifier: NCT02336347
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : July 13, 2015
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady state.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, 2-way Crossover Study Comparing AVP-786 With AVP-923
Study Start Date : May 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Nuedexta

Arm Intervention/treatment
Experimental: Group 1 - Period 1
Twice daily dosing of AVP-786 orally for 8 days
Drug: AVP-786
Other Name: deuterated (d6)-dextropmethorphan/quindine sulfate

Active Comparator: Group 1 - Period 2
Twice daily dosing of AVP-923 orally for 8 days
Drug: AVP-923
Other Name: dextromethorphan/quinidine

Active Comparator: Group 2 - Period 1
Twice daily dosing of AVP-923 orally for 8 days
Drug: AVP-923
Other Name: dextromethorphan/quinidine

Experimental: Group 2 - Period 2
Twice daily dosing of AVP-786 orally for 8 days
Drug: AVP-786
Other Name: deuterated (d6)-dextropmethorphan/quindine sulfate




Primary Outcome Measures :
  1. PK of d6-DM in AVP-786 compared to DM in AVP-923 [ Time Frame: 8 days ]

Secondary Outcome Measures :
  1. PK of metabolites [ Time Frame: 8 days ]
  2. Safety and tolerability [ Time Frame: 8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult males or females
  • 18 - 60 years of age
  • BMI 18 - 32 kg/m2

Exclusion Criteria:

  • History or presence of significant disease
  • History of substance abuse and/or alcohol abuse with the past 2 years
  • Use of tobacco-containing or nicotine-containing products within 6 months
  • 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): NCT02336347


Locations
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United States, Texas
Covance Dallas Clinical Research Unit
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Avanir Pharmaceuticals
Investigators
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Study Director: Nadine Knowles Avanir Pharmaceuticals

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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02336347     History of Changes
Other Study ID Numbers: 14-AVP-786-102
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: July 13, 2015
Last Verified: July 2015
Keywords provided by Avanir Pharmaceuticals:
Pharmacokinetics
Healthy Volunteers
deuterated dextromethorphan
deuterated dextromethorphan with quinidine
Additional relevant MeSH terms:
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Quinidine
Quinidine gluconate
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors