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A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02174835
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 the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Single-center, Randomized, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide/Quinidine Sulfate) in Healthy Volunteers
Study Start Date : September 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: Cohort A - Period 1
Twice daily dosing orally for 7 days
Drug: AVP-786
Active Comparator: Cohort A - Period 2
Twice daily dosing orally for 7 days
Drug: AVP-923
Experimental: Cohort A - Period 3
Twice daily dosing orally for 7 days
Drug: AVP-786
Experimental: Cohort B - Period 1
Twice daily dosing orally for 7 days
Drug: AVP-786
Active Comparator: Cohort B - Period 2
Twice daily dosing orally for 7 days
Drug: AVP-923
Experimental: Cohort B - Period 3
Twice daily dosing orally for 7 days
Drug: AVP-786



Primary Outcome Measures :
  1. Plasma concentrations of AVP-786 [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) for AVP-786 [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult males
  • 18 - 45 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): NCT02174835


Locations
Australia, South Australia
CMAX
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Avanir Pharmaceuticals
Investigators
Principal Investigator: Sepehr Shakib, M.D. CMAX

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02174835     History of Changes
Other Study ID Numbers: 13-AVR-134
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by Avanir Pharmaceuticals:
Pharmacokinetics
Healthy Volunteers
deuterated dextromethorphan
deuterated dextromethorphan with quinidine

Additional relevant MeSH terms:
Dextromethorphan
Quinidine
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