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Trial record 4 of 17 for:    avanir

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02174835
First received: June 23, 2014
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • Plasma concentrations of AVP-786 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events (AEs) for AVP-786 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: September 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  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: NCT02174835

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

No publications provided

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02174835     History of Changes
Other Study ID Numbers: 13-AVR-134
Study First Received: June 23, 2014
Last Updated: June 24, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Additional relevant MeSH terms:
Dextromethorphan
Antitussive Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015