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A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02174822
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and between AVP-786 and duloxetine.

Condition or disease Intervention/treatment Phase
Drug-drug Interaction Drug: AVP-786 Drug: Paroxetine Drug: Duloxetine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Single-center, Open-label, Sequential Drug Interaction Study Between AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [DM]/Quinidine Sulfate [Q]) and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
Study Start Date : January 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014


Arm Intervention/treatment
Experimental: Paroxetine + AVP-786
Paroxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20.
Drug: AVP-786
Drug: Paroxetine
Experimental: AVP-786 + paroxetine
AVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20
Drug: AVP-786
Drug: Paroxetine
Experimental: Duloxetine + AVP-786
Duloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13.
Drug: AVP-786
Drug: Duloxetine
Experimental: AVP-786 + duloxetine
AVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13.
Drug: AVP-786
Drug: Duloxetine



Primary Outcome Measures :
  1. Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects [ Time Frame: 20 days ]
  2. Change in plasma concentration of AVP-786 (parent and metabolites) after dosing in combination with paroxetine. [ Time Frame: 20 days ]
  3. Change in plasma concentration of duloxetine after combined dosing with AVP-786 [ Time Frame: 13 days ]
  4. Change in plasma concentration of AVP-786 after combined dosing with duloxetine. [ Time Frame: 13 days ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) for AVP-786 and paroxetine [ Time Frame: 20 days ]
  2. Incidence of adverse events (AEs) for AVP-786 and duloxetine [ Time Frame: 13 days ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult males and females
  • 18 - 50 years of age
  • BMI 18 - 30 kg/m2

Exclusion Criteria:

  • History or presence of significant disease
  • History of substance abuse and/or alcohol abuse with the past 3 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): NCT02174822


Locations
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Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Avanir Pharmaceuticals
Investigators
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Principal Investigator: Jason Lickliter, MBBS PhD FRACP Nucleus Network

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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02174822     History of Changes
Other Study ID Numbers: 14-AVP-786-101
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Keywords provided by Avanir Pharmaceuticals:
Drug-drug interaction
Pharmacokinetics
Healthy Volunteers
deuterated dextromethorphan
deuterated dextromethorphan with quinidine
Additional relevant MeSH terms:
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Quinidine
Duloxetine Hydrochloride
Dextromethorphan
Paroxetine
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents
Serotonin Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents